xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05962983</url>
    </required_header>
    <id_info>
      <org_study_id>H23-01062</org_study_id>
      <nct_id>NCT05962983</nct_id>
    </id_info>
    <brief_title>Small Steps for Big Changes - Recipe for Health</brief_title>
    <acronym>RFH</acronym>
    <official_title>A Recipe for Health: Evaluating the Effectiveness of a Diabetes Prevention Program on Dietary Behaviours and Diabetes Risk</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of British Columbia</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate changes in HbA1c levels, diet, weight and waist&#xD;
        circumference in Small Steps for Big Changes (SSBC) diabetes prevention program participants&#xD;
        two year after program completion compared to before they took part in the program.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. Are changes in caloric, carbohydrate, and fibre intake associated with HbA1c levels&#xD;
             after SSBC program completion in the short (3- and 6- months), medium (9- and 12-&#xD;
             months) and long-term (21- and 24- months)?&#xD;
  &#xD;
          2. Are changes in caloric, carbohydrate, and fibre intake associated with anthropometrics&#xD;
             (weight and waist circumference) after program completion in the short (3- and 6-&#xD;
             months), medium (9- and 12- months) and long-term (21- and 24- months)?&#xD;
  &#xD;
          3. Are eating motives associated with dietary intake in individuals with prediabetes?&#xD;
  &#xD;
          4. Does participation in SSBC result in changes to eating motives over time?&#xD;
  &#xD;
        It is hypothesized that:&#xD;
  &#xD;
          1. Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months&#xD;
             post-intervention.&#xD;
  &#xD;
          2. Dietary changes will be associated with weight and waist circumference at 3-, 6-, and&#xD;
             12-months post-intervention.&#xD;
  &#xD;
          3. Participants' eating motives are associated with their dietary intake.&#xD;
  &#xD;
          4. Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post&#xD;
             intervention.&#xD;
  &#xD;
        A total number of 250 individuals with prediabetes will be recruited to take part in a 6-week&#xD;
        diet and exercise changes program (SSBC). The program will be administered and facilitated by&#xD;
        the community facility trainers at YMCA locations. Participants will be asked to visit&#xD;
        Diabetes Prevention Research Group (DPRG) Lab in the University of British Columbia Okanagan&#xD;
        Campus for Hba1c (primary outcome), anthropometric measurements and dietary assessment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a one-group repeated measures design and the primary outcome is hemoglobin A1c%&#xD;
        (HbA1c%). There is no randomization of individuals to conditions. HbA1c will be measured&#xD;
        using point-of-care test at eight timepoints. Secondary outcomes include diet (caloric,&#xD;
        carbohydrate and fibre intake), anthropometrics (weight and waist circumference) and eating&#xD;
        motives.&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
        Given the importance of diet for HbA1c% improvement among those at risk of developing type 2&#xD;
        diabetes (T2D), the purpose of this study is to assess caloric, carbohydrate and fibre intake&#xD;
        in real-life settings and evaluate whether these dietary factors predict HbA1c levels over 24&#xD;
        months. Second, the researchers aim to investigate whether dietary changes predict weight and&#xD;
        waist circumference among the study participants. Further, food choices are determined by&#xD;
        many factors, including but not limited to biological, physiological, psychological and&#xD;
        socio-cultural factors. Subsequently, the investigators aim to explore whether participants'&#xD;
        motives for eating affect their dietary intake, and whether such motives change after&#xD;
        partaking in SSBC.&#xD;
  &#xD;
        Sample Size:&#xD;
  &#xD;
        A total sample size of 214 is required to detect an HbA1c change between the baseline and the&#xD;
        three follow-up segments. Linear trajectory was assumed between baseline and the 9-12-month&#xD;
        segment, then a stable trajectory to the 21-24 month segment. The trial is powered to detect&#xD;
        a clinically significant change across all segments. As such, the study is powered to detect&#xD;
        the smallest expected change in HbA1c, which occurred at the 3-6 month segment based on the&#xD;
        Phase IV effectiveness findings (d = .23) based on a previous RCT. Using G*Power, an initial&#xD;
        sample size of N = 178 was calculated assuming two-sided type-I error probability of 5% and a&#xD;
        power of 80%, d = .23 change in HbA1c at 3-6 months, and three covariates (age, sex, gender).&#xD;
        Informed by Phase IV trial statistics, the investigators increased the sample to account for&#xD;
        a &lt;17.2% loss to follow-up (178/.828 = 214). The community partner agreed to deliver SSBC&#xD;
        program to up to 250 individuals. Accordingly, 250 patients will be recruited.&#xD;
  &#xD;
        Recruitment:&#xD;
  &#xD;
        Participants will be primarily recruited through the Valley Medical Laboratories (Kelowna,&#xD;
        BC). Potentially eligible participants with an HbA1c of 5.7-6.4% will receive a flyer about&#xD;
        the program and contact the study team if they are interested. Community members may also&#xD;
        contact our research team directly if they are interested in participating.&#xD;
  &#xD;
        Trial Design:&#xD;
  &#xD;
        This study is a treatment-only repeated measures design. The investigators aim to recruit&#xD;
        adults with prediabetes to take part in the SSBC program with baseline measures taken at (-3)&#xD;
        months before and at the beginning of the program, immediate post-intervention (after session&#xD;
        6) and follow-up measurement time-points at 3-, 6-, 9-, 12-, 21-, and 24- months&#xD;
        post-intervention. The primary outcome is glycated hemoglobin (HbA1c). The secondary outcomes&#xD;
        are caloric, carbohydrate and fibre intake as well as weight and waist circumference. Eating&#xD;
        motives are also the secondary outcomes and predictor variables which will be dichotomized&#xD;
        into physiological (hungry, tired) and psychological motives (bored, stressed, sad, social,&#xD;
        eating time).&#xD;
  &#xD;
        Diet and Exercise Intervention (SSBC program) at Community Site:&#xD;
  &#xD;
        SSBC program will be delivered by partnering organization, the YMCA of Southern Interior.&#xD;
        Participants will receive diet and exercise counselling aimed at setting personalized goals,&#xD;
        improving self-monitoring skills, and self-regulatory efficacy. These consults are designed&#xD;
        to increase participants' adherence to healthy diet and regular exercise. Coaches highlight&#xD;
        healthy dietary strategies (reducing added sugar and refined/processed carbohydrate intake,&#xD;
        increasing vegetable consumption, reading food labels, Canadian Food Guide) that are linked&#xD;
        to reduced risk of T2D. Participants and coaches create detailed plans for how to meet their&#xD;
        goals and check in to discuss progress at each visit. Counselling sessions last approximately&#xD;
        20-30 minutes. Following counselling sessions, exercise sessions with a trained coach occur&#xD;
        over the course of the 6-week. Participants are supervised while they complete their chosen&#xD;
        form of aerobic exercise: 1) traditional continuous exercise that involves exercising at a&#xD;
        constant pace for 20-30 minutes (moderate-intensity continuous training, MICT); or 2)&#xD;
        interval exercise that involves alternating between 30 seconds and 1-minute of brisk exercise&#xD;
        and 1-minute of easy exercise for ~15 min (high-intensity interval training, HIIT). Both&#xD;
        exercise forms could be completed on treadmill, elliptical or stationary bike. The trained&#xD;
        coaches apply the principles of gradual progression. A combination of continuous MICT and&#xD;
        HIIT are used to increase enjoyment and variety, as well as encourage progression.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
          1. HbA1c: HbA1c% scores will be collected using the point-of-care HbA1c test at DPRG lab.&#xD;
             It is a simple finger-prick test that provides the patient's HbA1c value within minutes.&#xD;
             The HbA1c test indicates the sugar levels in the participant's blood without fasting.&#xD;
             Point-of-care assessment will be conducted using the World Health Organization (WHO)&#xD;
             guidelines for capillary sampling.&#xD;
  &#xD;
          2. Diet &amp; eating motives: Dietary outcomes and eating motives will be assessed through&#xD;
             Keenoa image based food tracking application. Keenoa is a smartphone imaged-based&#xD;
             dietary assessment application that recognizes and identifies food items using&#xD;
             artificial intelligence. To capture free-living diets, participants will be asked to&#xD;
             take pictures of their foods, snacks, and beverages for 3 days at each time point on&#xD;
             consecutive 2 weekdays and 1 weekend day. Participants can log packaged and processed&#xD;
             foods using the barcode scanner feature of the app. In addition to the food images,&#xD;
             participants will be asked to answer a multiple-choice question about their eating&#xD;
             motives through the app prior to each meal. They will be given the option to choose one&#xD;
             of the following reasons for eating: 'bored', 'stressed', 'sad', 'social', 'it's time',&#xD;
             'tired', or 'hungry'. Participants will complete the dietary assessment at home. Keenoa&#xD;
             sources its nutrient data from the Canadian Nutrient File, United States Department of&#xD;
             Agriculture, and Hong Kong Food Database, which makes it convenient to use in a study&#xD;
             conducted in Canada. To date, two validation studies comparing Keenoa with other dietary&#xD;
             assessment tools have been published. In addition to the acceptable validity, a&#xD;
             qualitative study found that Keenoa is user friendly and time saving.&#xD;
  &#xD;
          3. Weight &amp; waist circumference: Weight will be measured on a stadiometer. Waist&#xD;
             circumference will be measured at the top of the iliac crest (hip bone) using a tape.&#xD;
  &#xD;
        Statistical Analyses:&#xD;
  &#xD;
        An interrupted time-series design will be used to test client-level outcomes on an&#xD;
        intention-to-treat basis. Interrupted time-series consists of repeated outcome observations&#xD;
        across time, with a break in series corresponding to the introduction of an intervention. The&#xD;
        average of multiple baseline &quot;control phase&quot; assessments are compared to &quot;intervention phase&quot;&#xD;
        outcome trends to determine effectiveness. HbA1c will be assessed at 8 primary time points: 2&#xD;
        control phase assessments (3-months before, and at baseline [month &quot;0&quot;]) and 6 support phase&#xD;
        follow-up time points (3-, 6-, 9-, 12-, 21-, and 24-months post-intervention). The 3-month&#xD;
        periodization is clinically meaningful as the primary outcome of HbA1c reflects average blood&#xD;
        glucose over ~3 months. Two baseline assessments account for 6 months of pre-intervention&#xD;
        HbA1c measurement (i.e., 6-3 and 3-0 months pre-baseline), strengthening our ability to&#xD;
        detect meaningful change. Interrupted time series HbA1c data will be analyzed using a&#xD;
        piecewise &quot;segmented&quot; regression with four segments: | baseline | 3, 6 | 9, 12 | 21, 24 | to&#xD;
        indicate changes from baseline (0, -3 months) to early adoption (3-, 6-months&#xD;
        post-intervention), medium (9- and 12-months post-intervention), and long-term (21-,&#xD;
        24-months post-intervention) adherence. The researchers will adjust for time trends and&#xD;
        covariates (age and sex) by allowing for adjustment of both within-subject and within-site&#xD;
        correlations. A sensitivity analysis with missing data imputation will be conducted to&#xD;
        rule-out the potential impact of non-adherence on study outcomes.&#xD;
  &#xD;
        A repeated measures ANOVA will be performed to determine whether there are any differences in&#xD;
        dietary intake [caloric (kcal), carbohydrate (grams and %) and fibre (grams) intake] in&#xD;
        participants over time. A multiple regression will be performed to determine the relationship&#xD;
        between dietary intake [caloric (kcal), carbohydrate (grams and %) and fibre (grams) intake]&#xD;
        and HbA1c levels while controlling for confounding factors (i.e., age and sex). The&#xD;
        relationship between dietary behaviours, weight and waist circumference will be analyzed&#xD;
        using a multiple regression. Eating motives are predictor variables and will be dichotomized&#xD;
        into two groups: physiological (i.e., hungry, tired) and psychological (i.e., bored,&#xD;
        stressed, sad, social and eating time) eating motives. A binomial logistic regression will be&#xD;
        performed to evaluate whether eating motives are predictive of dietary intake.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This study is a treatment-only repeated measures design.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in hemoglobin A1c% (HbA1c%)</measure>
      <time_frame>8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.</time_frame>
      <description>HbA1c% provides a measure of the average glucose concentration over the past three months.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change in caloric intake (kcal)</measure>
      <time_frame>5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups</time_frame>
      <description>It refers to the number of calories (energy content) consumed during a day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in carbohydrate intake (grams)</measure>
      <time_frame>5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups</time_frame>
      <description>Carbohydrates are one of the three macronutrients in the human diet.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in fibre intake (grams)</measure>
      <time_frame>5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups</time_frame>
      <description>It refers to a group of substances in plant foods which cannot be completely broken down by human digestive enzymes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in weight (lbs)</measure>
      <time_frame>7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups</time_frame>
      <description>Participants' mass or weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in waist circumference (inches)</measure>
      <time_frame>7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups</time_frame>
      <description>It is the measurement taken at the top of the iliac crest (hip bone)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>eating motives</measure>
      <time_frame>5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups</time_frame>
      <description>reasons for eating (hungry, tired, bored, stressed, sad, social, eating time, other). A multiple question will be prompted to participants prior to every food intake through Keenoa food diet assessment tool.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>PreDiabetes</condition>
    <condition>Prediabetic State</condition>
    <arm_group>
      <arm_group_label>SSBC participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will attend a 6-week diet and exercise changes program (SSBC).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Small Steps for Big Changes Program</intervention_name>
      <description>Participants will be asked to attend six one on one sessions providing diet and exercise counselling each lasting 20-30 minutes over the course of six weeks. The nutrition counselling will introduce participants to a healthy dietary changes for reducing added sugar intake and refined/processed carbohydrate intake as well as increasing vegetable consumption. After counselling sessions, participants will complete their chosen form of aerobic exercise: 1) traditional continuous exercise that involves exercising at a constant pace for 20-30 minutes (moderate-intensity continuous training, MICT); or 2) interval exercise that involves alternating between 30 seconds and 1-minute of brisk exercise and 1-minute of easy exercise for ~15 min (high-intensity interval training, HIIT). Both exercise forms could be completed on treadmill, elliptical or stationary bike. In total, each session will last approximately one hour.</description>
      <arm_group_label>SSBC participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults over the age of 18 and able to read and speak English&#xD;
  &#xD;
            -  living with prediabetes: HbA1c% values between 5.7-6.4% (American Diabetes&#xD;
               Association, 2012), or&#xD;
  &#xD;
            -  individuals diagnosed with type 2 diabetes in remission, defined as achieving HbA1c of&#xD;
               &lt; 6.4% without any diabetes-related medications for a minimum of 3 months (Diabetes&#xD;
               Canada Clinical Practice Guidelines, 2022), or&#xD;
  &#xD;
            -  individuals at high risk of developing type 2 diabetes defined as an American Diabetes&#xD;
               Association risk questionnaire score ≥ 5.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  failure to obtain participant's signed declaration for the Get Active questionnaire&#xD;
  &#xD;
            -  currently diagnosed with type 2 diabetes with an HbA1c of 6.5% or greater&#xD;
  &#xD;
            -  pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mary E Jung, PhD</last_name>
      <phone>(250) 807-9670</phone>
      <email>mary.jung@ubc.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Azize N Yildirim, MSc</last_name>
      <phone>(778) 363-8033</phone>
      <email>azize@student.ubc.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of British Columbia</name>
        <address>
          <city>Kelowna</city>
          <state>British Columbia</state>
          <zip>V1V 1V7</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of British Columbia</investigator_affiliation>
      <investigator_full_name>Mary Jung</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>dietary assessment</keyword>
    <keyword>type 2 diabetes</keyword>
    <keyword>diabetes prevention</keyword>
    <keyword>behaviour change</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962983
  org study id: H23-01062
  nct id: NCT05962983
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate changes in HbA1c levels, diet, weight and waist
        circumference in Small Steps for Big Changes (SSBC) diabetes prevention program participants
        two year after program completion compared to before they took part in the program.
  
        The main questions it aims to answer are:
  
          1. Are changes in caloric, carbohydrate, and fibre intake associated with HbA1c levels
             after SSBC program completion in the short (3- and 6- months), medium (9- and 12-
             months) and long-term (21- and 24- months)?
  
          2. Are changes in caloric, carbohydrate, and fibre intake associated with anthropometrics
             (weight and waist circumference) after program completion in the short (3- and 6-
             months), medium (9- and 12- months) and long-term (21- and 24- months)?
  
          3. Are eating motives associated with dietary intake in individuals with prediabetes?
  
          4. Does participation in SSBC result in changes to eating motives over time?
  
        It is hypothesized that:
  
          1. Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months
             post-intervention.
  
          2. Dietary changes will be associated with weight and waist circumference at 3-, 6-, and
             12-months post-intervention.
  
          3. Participants' eating motives are associated with their dietary intake.
  
          4. Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post
             intervention.
  
        A total number of 250 individuals with prediabetes will be recruited to take part in a 6-week
        diet and exercise changes program (SSBC). The program will be administered and facilitated by
        the community facility trainers at YMCA locations. Participants will be asked to visit
        Diabetes Prevention Research Group (DPRG) Lab in the University of British Columbia Okanagan
        Campus for Hba1c (primary outcome), anthropometric measurements and dietary assessment.
  The study is a one-group repeated measures design and the primary outcome is hemoglobin A1c%
        (HbA1c%). There is no randomization of individuals to conditions. HbA1c will be measured
        using point-of-care test at eight timepoints. Secondary outcomes include diet (caloric,
        carbohydrate and fibre intake), anthropometrics (weight and waist circumference) and eating
        motives.
  
        Objectives:
  
        Given the importance of diet for HbA1c% improvement among those at risk of developing type 2
        diabetes (T2D), the purpose of this study is to assess caloric, carbohydrate and fibre intake
        in real-life settings and evaluate whether these dietary factors predict HbA1c levels over 24
        months. Second, the researchers aim to investigate whether dietary changes predict weight and
        waist circumference among the study participants. Further, food choices are determined by
        many factors, including but not limited to biological, physiological, psychological and
        socio-cultural factors. Subsequently, the investigators aim to explore whether participants'
        motives for eating affect their dietary intake, and whether such motives change after
        partaking in SSBC.
  
        Sample Size:
  
        A total sample size of 214 is required to detect an HbA1c change between the baseline and the
        three follow-up segments. Linear trajectory was assumed between baseline and the 9-12-month
        segment, then a stable trajectory to the 21-24 month segment. The trial is powered to detect
        a clinically significant change across all segments. As such, the study is powered to detect
        the smallest expected change in HbA1c, which occurred at the 3-6 month segment based on the
        Phase IV effectiveness findings (d = .23) based on a previous RCT. Using G*Power, an initial
        sample size of N = 178 was calculated assuming two-sided type-I error probability of 5% and a
        power of 80%, d = .23 change in HbA1c at 3-6 months, and three covariates (age, sex, gender).
        Informed by Phase IV trial statistics, the investigators increased the sample to account for
        a <17.2% loss to follow-up (178/.828 = 214). The community partner agreed to deliver SSBC
        program to up to 250 individuals. Accordingly, 250 patients will be recruited.
  
        Recruitment:
  
        Participants will be primarily recruited through the Valley Medical Laboratories (Kelowna,
        BC). Potentially eligible participants with an HbA1c of 5.7-6.4% will receive a flyer about
        the program and contact the study team if they are interested. Community members may also
        contact our research team directly if they are interested in participating.
  
        Trial Design:
  
        This study is a treatment-only repeated measures design. The investigators aim to recruit
        adults with prediabetes to take part in the SSBC program with baseline measures taken at (-3)
        months before and at the beginning of the program, immediate post-intervention (after session
        6) and follow-up measurement time-points at 3-, 6-, 9-, 12-, 21-, and 24- months
        post-intervention. The primary outcome is glycated hemoglobin (HbA1c). The secondary outcomes
        are caloric, carbohydrate and fibre intake as well as weight and waist circumference. Eating
        motives are also the secondary outcomes and predictor variables which will be dichotomized
        into physiological (hungry, tired) and psychological motives (bored, stressed, sad, social,
        eating time).
  
        Diet and Exercise Intervention (SSBC program) at Community Site:
  
        SSBC program will be delivered by partnering organization, the YMCA of Southern Interior.
        Participants will receive diet and exercise counselling aimed at setting personalized goals,
        improving self-monitoring skills, and self-regulatory efficacy. These consults are designed
        to increase participants' adherence to healthy diet and regular exercise. Coaches highlight
        healthy dietary strategies (reducing added sugar and refined/processed carbohydrate intake,
        increasing vegetable consumption, reading food labels, Canadian Food Guide) that are linked
        to reduced risk of T2D. Participants and coaches create detailed plans for how to meet their
        goals and check in to discuss progress at each visit. Counselling sessions last approximately
        20-30 minutes. Following counselling sessions, exercise sessions with a trained coach occur
        over the course of the 6-week. Participants are supervised while they complete their chosen
        form of aerobic exercise: 1) traditional continuous exercise that involves exercising at a
        constant pace for 20-30 minutes (moderate-intensity continuous training, MICT); or 2)
        interval exercise that involves alternating between 30 seconds and 1-minute of brisk exercise
        and 1-minute of easy exercise for ~15 min (high-intensity interval training, HIIT). Both
        exercise forms could be completed on treadmill, elliptical or stationary bike. The trained
        coaches apply the principles of gradual progression. A combination of continuous MICT and
        HIIT are used to increase enjoyment and variety, as well as encourage progression.
  
        Data Collection:
  
          1. HbA1c: HbA1c% scores will be collected using the point-of-care HbA1c test at DPRG lab.
             It is a simple finger-prick test that provides the patient's HbA1c value within minutes.
             The HbA1c test indicates the sugar levels in the participant's blood without fasting.
             Point-of-care assessment will be conducted using the World Health Organization (WHO)
             guidelines for capillary sampling.
  
          2. Diet & eating motives: Dietary outcomes and eating motives will be assessed through
             Keenoa image based food tracking application. Keenoa is a smartphone imaged-based
             dietary assessment application that recognizes and identifies food items using
             artificial intelligence. To capture free-living diets, participants will be asked to
             take pictures of their foods, snacks, and beverages for 3 days at each time point on
             consecutive 2 weekdays and 1 weekend day. Participants can log packaged and processed
             foods using the barcode scanner feature of the app. In addition to the food images,
             participants will be asked to answer a multiple-choice question about their eating
             motives through the app prior to each meal. They will be given the option to choose one
             of the following reasons for eating: 'bored', 'stressed', 'sad', 'social', 'it's time',
             'tired', or 'hungry'. Participants will complete the dietary assessment at home. Keenoa
             sources its nutrient data from the Canadian Nutrient File, United States Department of
             Agriculture, and Hong Kong Food Database, which makes it convenient to use in a study
             conducted in Canada. To date, two validation studies comparing Keenoa with other dietary
             assessment tools have been published. In addition to the acceptable validity, a
             qualitative study found that Keenoa is user friendly and time saving.
  
          3. Weight & waist circumference: Weight will be measured on a stadiometer. Waist
             circumference will be measured at the top of the iliac crest (hip bone) using a tape.
  
        Statistical Analyses:
  
        An interrupted time-series design will be used to test client-level outcomes on an
        intention-to-treat basis. Interrupted time-series consists of repeated outcome observations
        across time, with a break in series corresponding to the introduction of an intervention. The
        average of multiple baseline "control phase" assessments are compared to "intervention phase"
        outcome trends to determine effectiveness. HbA1c will be assessed at 8 primary time points: 2
        control phase assessments (3-months before, and at baseline [month "0"]) and 6 support phase
        follow-up time points (3-, 6-, 9-, 12-, 21-, and 24-months post-intervention). The 3-month
        periodization is clinically meaningful as the primary outcome of HbA1c reflects average blood
        glucose over ~3 months. Two baseline assessments account for 6 months of pre-intervention
        HbA1c measurement (i.e., 6-3 and 3-0 months pre-baseline), strengthening our ability to
        detect meaningful change. Interrupted time series HbA1c data will be analyzed using a
        piecewise "segmented" regression with four segments: | baseline | 3, 6 | 9, 12 | 21, 24 | to
        indicate changes from baseline (0, -3 months) to early adoption (3-, 6-months
        post-intervention), medium (9- and 12-months post-intervention), and long-term (21-,
        24-months post-intervention) adherence. The researchers will adjust for time trends and
        covariates (age and sex) by allowing for adjustment of both within-subject and within-site
        correlations. A sensitivity analysis with missing data imputation will be conducted to
        rule-out the potential impact of non-adherence on study outcomes.
  
        A repeated measures ANOVA will be performed to determine whether there are any differences in
        dietary intake [caloric (kcal), carbohydrate (grams and %) and fibre (grams) intake] in
        participants over time. A multiple regression will be performed to determine the relationship
        between dietary intake [caloric (kcal), carbohydrate (grams and %) and fibre (grams) intake]
        and HbA1c levels while controlling for confounding factors (i.e., age and sex). The
        relationship between dietary behaviours, weight and waist circumference will be analyzed
        using a multiple regression. Eating motives are predictor variables and will be dichotomized
        into two groups: physiological (i.e., hungry, tired) and psychological (i.e., bored,
        stressed, sad, social and eating time) eating motives. A binomial logistic regression will be
        performed to evaluate whether eating motives are predictive of dietary intake.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This study is a treatment-only repeated measures design.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: change in hemoglobin A1c% (HbA1c%)
  time frame: 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.
  description: HbA1c% provides a measure of the average glucose concentration over the past three months.
  measure: change in caloric intake (kcal)
  time frame: 5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups
  description: It refers to the number of calories (energy content) consumed during a day.
  measure: change in carbohydrate intake (grams)
  time frame: 5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups
  description: Carbohydrates are one of the three macronutrients in the human diet.
  measure: change in fibre intake (grams)
  time frame: 5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups
  description: It refers to a group of substances in plant foods which cannot be completely broken down by human digestive enzymes.
  measure: change in weight (lbs)
  time frame: 7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups
  description: Participants' mass or weight
  measure: change in waist circumference (inches)
  time frame: 7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups
  description: It is the measurement taken at the top of the iliac crest (hip bone)
  measure: eating motives
  time frame: 5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups
  description: reasons for eating (hungry, tired, bored, stressed, sad, social, eating time, other). A multiple question will be prompted to participants prior to every food intake through Keenoa food diet assessment tool.
  arm group label: SSBC participants
  arm group type: Experimental
  description: Participants will attend a 6-week diet and exercise changes program (SSBC).
  intervention type: Behavioral
  intervention name: Small Steps for Big Changes Program
  description: Participants will be asked to attend six one on one sessions providing diet and exercise counselling each lasting 20-30 minutes over the course of six weeks. The nutrition counselling will introduce participants to a healthy dietary changes for reducing added sugar intake and refined/processed carbohydrate intake as well as increasing vegetable consumption. After counselling sessions, participants will complete their chosen form of aerobic exercise: 1) traditional continuous exercise that involves exercising at a constant pace for 20-30 minutes (moderate-intensity continuous training, MICT); or 2) interval exercise that involves alternating between 30 seconds and 1-minute of brisk exercise and 1-minute of easy exercise for ~15 min (high-intensity interval training, HIIT). Both exercise forms could be completed on treadmill, elliptical or stationary bike. In total, each session will last approximately one hour.
  arm group label: SSBC participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mary E Jung, PhD
  phone: (250) 807-9670
  email: mary.jung@ubc.ca
  last name: Azize N Yildirim, MSc
  phone: (778) 363-8033
  email: azize@student.ubc.ca
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: Mary Jung
  investigator title: Associate Professor
  mesh term: Prediabetic State
  sharing ipd: No