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/NCT06022796</url>
    </required_header>
    <id_info>
      <org_study_id>202300165</org_study_id>
      <nct_id>NCT06022796</nct_id>
    </id_info>
    <brief_title>Weight Loss Interventions for Obesity</brief_title>
    <official_title>Weight Loss Interventions for Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National University Hospital, Singapore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National University Hospital, Singapore</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>
        Numerous barriers towards weight management among Singaporeans with obesity exists, which&#xD;
        involves environmental and self-regulation factors (i.e. motivation and hunger). Hence, the&#xD;
        provision of healthy ketogenic ready-to-eat meals may be a potential solution to facilitate&#xD;
        initial weight loss through increasing motivation while reducing appetite and hunger levels&#xD;
        among these individuals. Therefore, this study will investigate the effect of healthy&#xD;
        ketogenic ready-to-eat meals with mHealth nutrition application versus healthy ketogenic diet&#xD;
        (without meal provision) with the mHealth nutrition app to facilitate weight loss and improve&#xD;
        metabolic outcomes among individuals with obesity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In Singapore, the widespread availability of local meals and concerns of overconsumption due&#xD;
        to a lack of internal self-regulation skills for hunger predisposes an increased energy&#xD;
        intake. Furthermore, a lack of time, motivation, and self-efficacy in preparing healthy meals&#xD;
        may potentially limit the extent of weight and dietary management among local individuals&#xD;
        with obesity.&#xD;
  &#xD;
        The ketogenic diet has consistently demonstrated beneficial effects on facilitating weight&#xD;
        management. This weight loss mechanism involves achieving a calorie deficit, induced state of&#xD;
        nutritional ketosis, and the reduction in appetite and hunger. Importantly, the weight loss&#xD;
        achieved from the early phase of the intervention serves as one of the key enablers in the&#xD;
        weight loss process. Despite these benefits, there is paucity in the literature examining the&#xD;
        provision of healthy ketogenic ready-to-eat (HK-RTE) meals on weight loss. Furthermore, none&#xD;
        of these studies explored the extent of motivation derived from the benefits of these meals,&#xD;
        nor included the use of mHealth self-monitoring strategies to encourage weight loss.&#xD;
  &#xD;
        To address the research gap, our study aims to evaluate the effectiveness of HK-RTE meals&#xD;
        with mHealth app, as compared to healthy ketogenic diet (HKD) (without meal provision) using&#xD;
        the mHealth app on weight loss and metabolic outcomes among Asian individuals with obesity.&#xD;
  &#xD;
        In this randomized controlled trial, participants will be randomized to either HK-RTE group&#xD;
        or the HKD group using computer-generated random sequencing. Both groups will receive&#xD;
        nutrition education conducted by dietitians throughout the 6-month study period (total of 5&#xD;
        dietary workshops covering topics such as ketogenic dietary advice and self-monitoring&#xD;
        habits).&#xD;
  &#xD;
        The HK-RTE group will be provided with HK-RTE meals for lunch and dinner in the first month&#xD;
        (n = 25). They are to take these meals as part of a healthy ketogenic diet, with a maximum of&#xD;
        50g net total carbohydrates daily. Those in the control group will be advised to follow a&#xD;
        healthy ketogenic diet (HKD) without the RTE meals (n = 25) and similarly to keep to a&#xD;
        maximum of 50g net carbohydrates daily. Participants will also be encouraged to use the&#xD;
        Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake,&#xD;
        physical activity and weight throughout the 6-month study period. The impact of the HK-RTE&#xD;
        meals on motivation and appetite regulation in influencing weight loss will also be explored.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>In this randomized controlled trial, participants in the HK-RTE group will be advised to follow a healthy ketogenic diet with RTE meals provided (n=25), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a healthy ketogenic diet (HKD) (n=25).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>It is not feasible to apply blinding to the study design due to the nature of the intervention</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Body weight</measure>
      <time_frame>1 month, 3 months, 6 months</time_frame>
      <description>Weight changes post-intervention</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Systolic and diastolic changes at follow up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1c</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>HbA1c changes at follow up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasting blood glucose</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Fasting blood glucose changes at follow up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Cholesterol changes at follow up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low-density lipoprotein cholesterol</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Cholesterol changes at follow up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High-density lipoprotein cholesterol</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Cholesterol changes at follow-up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Triglycerides changes at follow up appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation to initiate and maintain dietary behaviours</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Motivation via self-reported questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived competence to maintain dietary behaviour</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Perceived competence via self-reported questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hunger</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Subjective ratings of hunger feelings via self-reported questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>6 months</time_frame>
      <description>Nutrients intake by assessing food logs in nBuddy application</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Overweight</condition>
    <condition>Weight Loss</condition>
    <condition>Ketogenic Dieting</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the HK-RTE group (n=25) will be provided with the Healthfull meals for lunch and dinner in the first month. They will be advised to take these meals as part of a healthy ketogenic diet, with a maximum of 50g total net carbohydrates daily.&#xD;
  Participants will receive nutrition education conducted by dietitians over the course of 6 months (total of 5 dietary workshops covering topics such as ketogenic dietary advice and self-monitoring habits). Participants will also receive health coaching via the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6 months study period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Ketogenic Diet (HKD)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the reference group will be instructed to follow a Healthy Ketogenic Diet (n = 25), with a maximum of 50g total net carbohydrates daily.&#xD;
  Similar to the experimental group, participants will receive nutrition education conducted by dietitians over the course of 6 months (total of 5 dietary workshops such as ketogenic dietary advice and self-monitoring habit). Participants will also receive health coaching via the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6 months study period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Healthy Ketogenic Ready-to-Eat Meals</intervention_name>
      <description>Participants will be provided nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet. In addition, HK-RTE meals will be provided to participants as a form of meal replacement for lunch and dinner over 1 month. Participants will be expected to follow a healthy ketogenic diet thereafter.</description>
      <arm_group_label>Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals</arm_group_label>
      <other_name>Very low carbohydrate diet</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Healthy Ketogenic Diet</intervention_name>
      <description>Participants will receive nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet, without the provision of HK-RTE meals.</description>
      <arm_group_label>Healthy Ketogenic Diet (HKD)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 21 to 75 years old&#xD;
  &#xD;
            -  Body Mass Index &gt;= 27.5kg/m2&#xD;
  &#xD;
            -  Own a smartphone&#xD;
  &#xD;
            -  Literacy in English&#xD;
  &#xD;
            -  NUH staff&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intention of pregnancy; Pregnancy; Lactating individuals&#xD;
  &#xD;
            -  Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus on insulin treatment&#xD;
  &#xD;
            -  Untreated Endocrinopathy (e.g., hyper/hypothyroidism)&#xD;
  &#xD;
            -  Advanced kidney disease&#xD;
  &#xD;
            -  Abnormal liver function test assessed at screening&#xD;
  &#xD;
            -  Heart diseases&#xD;
  &#xD;
            -  Severe cognitive or psychiatric disabilities/disorders (e.g., eating disorders,&#xD;
               depression)&#xD;
  &#xD;
            -  Active malignancies&#xD;
  &#xD;
            -  Taking medications that affect appetite or induce weight loss; previous or plans for&#xD;
               bariatric surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Melissa Tay</last_name>
      <phone>67725166</phone>
      <email>melissa_hj_tay@nuhs.edu.sg</email>
    </overall_contact>
    <location>
      <facility>
        <name>National University Hospital</name>
        <address>
          <city>Singapore</city>
          <zip>119074</zip>
          <country>Singapore</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Melissa Tay</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <!-- 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/NCT06022796
  org study id: 202300165
  nct id: NCT06022796
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Numerous barriers towards weight management among Singaporeans with obesity exists, which
        involves environmental and self-regulation factors (i.e. motivation and hunger). Hence, the
        provision of healthy ketogenic ready-to-eat meals may be a potential solution to facilitate
        initial weight loss through increasing motivation while reducing appetite and hunger levels
        among these individuals. Therefore, this study will investigate the effect of healthy
        ketogenic ready-to-eat meals with mHealth nutrition application versus healthy ketogenic diet
        (without meal provision) with the mHealth nutrition app to facilitate weight loss and improve
        metabolic outcomes among individuals with obesity.
  In Singapore, the widespread availability of local meals and concerns of overconsumption due
        to a lack of internal self-regulation skills for hunger predisposes an increased energy
        intake. Furthermore, a lack of time, motivation, and self-efficacy in preparing healthy meals
        may potentially limit the extent of weight and dietary management among local individuals
        with obesity.
  
        The ketogenic diet has consistently demonstrated beneficial effects on facilitating weight
        management. This weight loss mechanism involves achieving a calorie deficit, induced state of
        nutritional ketosis, and the reduction in appetite and hunger. Importantly, the weight loss
        achieved from the early phase of the intervention serves as one of the key enablers in the
        weight loss process. Despite these benefits, there is paucity in the literature examining the
        provision of healthy ketogenic ready-to-eat (HK-RTE) meals on weight loss. Furthermore, none
        of these studies explored the extent of motivation derived from the benefits of these meals,
        nor included the use of mHealth self-monitoring strategies to encourage weight loss.
  
        To address the research gap, our study aims to evaluate the effectiveness of HK-RTE meals
        with mHealth app, as compared to healthy ketogenic diet (HKD) (without meal provision) using
        the mHealth app on weight loss and metabolic outcomes among Asian individuals with obesity.
  
        In this randomized controlled trial, participants will be randomized to either HK-RTE group
        or the HKD group using computer-generated random sequencing. Both groups will receive
        nutrition education conducted by dietitians throughout the 6-month study period (total of 5
        dietary workshops covering topics such as ketogenic dietary advice and self-monitoring
        habits).
  
        The HK-RTE group will be provided with HK-RTE meals for lunch and dinner in the first month
        (n = 25). They are to take these meals as part of a healthy ketogenic diet, with a maximum of
        50g net total carbohydrates daily. Those in the control group will be advised to follow a
        healthy ketogenic diet (HKD) without the RTE meals (n = 25) and similarly to keep to a
        maximum of 50g net carbohydrates daily. Participants will also be encouraged to use the
        Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake,
        physical activity and weight throughout the 6-month study period. The impact of the HK-RTE
        meals on motivation and appetite regulation in influencing weight loss will also be explored.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In this randomized controlled trial, participants in the HK-RTE group will be advised to follow a healthy ketogenic diet with RTE meals provided (n=25), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a healthy ketogenic diet (HKD) (n=25).
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: It is not feasible to apply blinding to the study design due to the nature of the intervention
  measure: Body weight
  time frame: 1 month, 3 months, 6 months
  description: Weight changes post-intervention
  measure: Blood pressure
  time frame: 3 months, 6 months
  description: Systolic and diastolic changes at follow up appointments
  measure: Hemoglobin A1c
  time frame: 3 months, 6 months
  description: HbA1c changes at follow up appointments
  measure: Fasting blood glucose
  time frame: 3 months, 6 months
  description: Fasting blood glucose changes at follow up appointments
  measure: Total cholesterol
  time frame: 3 months, 6 months
  description: Cholesterol changes at follow up appointments
  measure: Low-density lipoprotein cholesterol
  time frame: 3 months, 6 months
  description: Cholesterol changes at follow up appointments
  measure: High-density lipoprotein cholesterol
  time frame: 3 months, 6 months
  description: Cholesterol changes at follow-up appointments
  measure: Triglycerides
  time frame: 3 months, 6 months
  description: Triglycerides changes at follow up appointments
  measure: Motivation to initiate and maintain dietary behaviours
  time frame: 3 months, 6 months
  description: Motivation via self-reported questionnaire
  measure: Perceived competence to maintain dietary behaviour
  time frame: 3 months, 6 months
  description: Perceived competence via self-reported questionnaire
  measure: Hunger
  time frame: 3 months, 6 months
  description: Subjective ratings of hunger feelings via self-reported questionnaire
  measure: Dietary intake
  time frame: 6 months
  description: Nutrients intake by assessing food logs in nBuddy application
  arm group label: Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals
  arm group type: Experimental
  description: Participants in the HK-RTE group (n=25) will be provided with the Healthfull meals for lunch and dinner in the first month. They will be advised to take these meals as part of a healthy ketogenic diet, with a maximum of 50g total net carbohydrates daily.
  Participants will receive nutrition education conducted by dietitians over the course of 6 months (total of 5 dietary workshops covering topics such as ketogenic dietary advice and self-monitoring habits). Participants will also receive health coaching via the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6 months study period.
  arm group label: Healthy Ketogenic Diet (HKD)
  arm group type: Active Comparator
  description: Participants in the reference group will be instructed to follow a Healthy Ketogenic Diet (n = 25), with a maximum of 50g total net carbohydrates daily.
  Similar to the experimental group, participants will receive nutrition education conducted by dietitians over the course of 6 months (total of 5 dietary workshops such as ketogenic dietary advice and self-monitoring habit). Participants will also receive health coaching via the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6 months study period.
  intervention type: Other
  intervention name: Healthy Ketogenic Ready-to-Eat Meals
  description: Participants will be provided nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet. In addition, HK-RTE meals will be provided to participants as a form of meal replacement for lunch and dinner over 1 month. Participants will be expected to follow a healthy ketogenic diet thereafter.
  arm group label: Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals
  other name: Very low carbohydrate diet
  intervention type: Other
  intervention name: Healthy Ketogenic Diet
  description: Participants will receive nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet, without the provision of HK-RTE meals.
  arm group label: Healthy Ketogenic Diet (HKD)
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Melissa Tay
  phone: 67725166
  email: melissa_hj_tay@nuhs.edu.sg
  facility: 
  status: Recruiting
  contact: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Overweight
  mesh term: Body Weight
  mesh term: Weight Loss