<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/NCT03826394</url>
  </required_header>
  <id_info>
    <org_study_id>NottinghamTU</org_study_id>
    <nct_id>NCT03826394</nct_id>
  </id_info>
  <brief_title>Lifestyle Interventions in Overweight and Obese Postpartum Women</brief_title>
  <official_title>The Effects of Exercise and Dietary Interventions in Overweight and Obese Postpartum Women on Weight Management and Health.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham Trent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham Trent University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study aims to investigate the effects of a chosen technology-based exercise or&#xD;
      healthy eating intervention that combines individual and group-based support, on weight loss&#xD;
      and other health-related parameters in postpartum women with overweight or obesity. All&#xD;
      participants will be asked to engage in a 20-week programme consisting of a 4 week tracked&#xD;
      free living period followed by a 16-week intervention. The investigators hypothesise that&#xD;
      reductions in BMI (body mass index) and improvements in health-related parameters will be&#xD;
      observed post-intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study will investigate the effects of a chosen exercise or dietary intervention&#xD;
      on BMI and other health-related parameters in postpartum women with overweight and obesity.&#xD;
      Dietary or physical activity interventions, alone or combined, are associated with greater&#xD;
      weight loss when provided to women in the postpartum period, compared with no intervention.&#xD;
      Providing a combined physical activity and dietary intervention is associated with an average&#xD;
      weight loss of 2.49kg post-intervention and 2.4kg 12 months after pregnancy. However, the&#xD;
      variation in average weight loss achieved is great which could be due to differences in the&#xD;
      design of lifestyle programmes.&#xD;
&#xD;
      Interventions including individualised support and self-monitoring have proven more effective&#xD;
      in promoting reductions in BMI in postpartum women. However, high levels of attrition and&#xD;
      poor engagement have been highlighted as two areas that require attention in this area.&#xD;
      Therefore, future research is required to identify strategies best suited to the design and&#xD;
      implementation of effective lifestyle interventions in overweight and obese postpartum women.&#xD;
&#xD;
      Women between six weeks and one year postpartum will elect to be part of either a 16-week&#xD;
      exercise or dietary intervention. Prior to this, participants will be tracked for a period of&#xD;
      four weeks in free living conditions. Each intervention will be split into four blocks of&#xD;
      three weeks where staged intervention specific information will be provided. Individualised&#xD;
      face-to-face and technological group support will be provided throughout. For the final four&#xD;
      weeks of the intervention no new information will be provided and all support will be&#xD;
      withdrawn.&#xD;
&#xD;
      Analyses of body composition and girths, blood metabolites, resting heart rate, blood&#xD;
      pressure, and questionnaires assessing physical activity, eating behaviours and quality of&#xD;
      life will be carried out alongside assessments of BMI at baseline, pre-intervention and at&#xD;
      both twelve and sixteen weeks of the intervention. Measures of BMI, resting heart rate, blood&#xD;
      pressure and questionnaire scores will be taken at each three weekly stage of the&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 19, 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will take part in an exercise or dietary intervention in a non-randomised, parallel study.&#xD;
Each intervention will be preceded by a four week tracked free-living period. Both interventions will be completed over a sixteen week period. Following the tracked period, participants will choose to take part in either the exercise or dietary intervention. Intervention information will be delivered in four, three week blocks. No new information will be provided during the final four weeks of the intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in BMI</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Weight (kg) and height (m) will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Week 0, 4, 16, 20</time_frame>
    <description>Whole body DXA (dual energy X-ray absorptiometry) scan to assess fat mass, fat-free mass, bone density.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Blood Metabolites</measure>
    <time_frame>Week 0, 4, 16, 20</time_frame>
    <description>Fingertip blood sample taken to assess total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glycated haemoglobin, random glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Girths</measure>
    <time_frame>Week 0, 4, 16, 20</time_frame>
    <description>Measures (in cm) of waist, hip, thigh, calf, bust and upper arm girths.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Blood Pressure</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Measure of blood pressure taken at rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting Heart Rate</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Measure of heart rate taken at rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Assessment of quality of life using the Impact of Weight on Quality on Life (Lite) and Short-Form 36 Questionnaires.&#xD;
Short-Form 36- scores range from 0-100 (lower scores= more disability; higher scores = less disability).&#xD;
Impact of Weight on Quality of Life- 31-item that calculates a total score and scores on 5 separate domains (physical function, self-esteem, sexual life, public distress, work).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Quality</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Assessment of sleep quality using Pittsburgh Sleep Quality Index Questionnaire. Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate. Only self-rated questions are included in the scoring. Self-rated items are combined to form 7 component scores, each of which has a range of 0-3 points. A score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The 7 components scores are then summed together to yield one global score, with a range of 0-21 points. 0 indicates no difficulty and 21 indicates severe difficulties in all areas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Eating Behaviours</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Assessment of eating behaviours using Three Factor Eating Questionnaire. Responses to each of the 18 items are given a score of between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity Levels</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Measures of physical activity levels through direct (Fitbit) and indirect (Godin 7-day leisure time physical activity questionnaire) measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Markers of Postnatal Depression</measure>
    <time_frame>Week 0, 4, 7, 10, 13, 16, 20</time_frame>
    <description>Assessment of markers of depression using Edinburgh Postnatal Depression Scale. Responses to each of the 10 items are given a score of 0 to 3. The maximum score is 30. Higher scores indicate greater degrees of depression, with a score of 13 or above indicating varying degrees of depressive illness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise intervention with the aim of incrementally increasing physical activity to meet the national recommendation of 150 minutes a week of moderate-vigorous physical activity, reducing BMI and improving overall health.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Staged dietary intervention with the aim of improving eating behaviours, reducing BMI and improving overall health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Education based sixteen week intervention where participants will be provided with core information every three weeks and supplementary information through technological means at other time points. All provided information will be exercise specific. Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks. Fitbit Flex 2 provided for the duration of the study.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <other_name>Physical Activity Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Education based sixteen week intervention where participants will be provided with core information every three weeks and supplementary information through technological means at other time points. All provided information will be diet specific. Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks. Fitbit Flex 2 provided for the duration of the study.</description>
    <arm_group_label>Dietary Intervention</arm_group_label>
    <other_name>Nutritional Intervention/Healthy eating Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Be at least 18 years old at the date of their first visit. Have a body mass index (BMI) of&#xD;
        greater than 25 kg∙m2 (this will be worked out by the researchers using the participant's&#xD;
        height and body weight). Have had a singleton pregnancy. Have had one pregnancy to date. Be&#xD;
        6 weeks-1 year postpartum (and had physician's approval to return to exercise).&#xD;
&#xD;
        Own a smartphone (able to download and use WhatsApp). In the researcher's opinion, the&#xD;
        participant is able and willing to follow all trial requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Have a clinical diagnosis of depression/postnatal depression. Currently enrolled on another&#xD;
        weight loss programme. Currently consuming weight loss tablets/supplements. Have&#xD;
        heart/liver/chronic renal disease. Have a clinical diagnosis of Type 2 Diabetes Mellitus.&#xD;
        Consume excessive amounts of alcohol (regularly drinking more than 14 units of alcohol a&#xD;
        week). Actively trying for another baby/planning a pregnancy in the next 6 months.&#xD;
        Experienced a stillbirth. Have any health conditions that affect physical activity&#xD;
        engagement. On any medication that affects the ability to exercise. On any medication that&#xD;
        affects the ability to follow a healthy eating programme.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie J Hanley, MRes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nottingham Trent University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie J Hanley, MRes</last_name>
    <phone>07414542237</phone>
    <email>stephanie.hanley2016@my.ntu.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kirsty J Elliott-Sale, PhD</last_name>
    <phone>01158486338</phone>
    <email>kirsty.elliottsale@ntu.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nottingham Trent University, Clifton Campus</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG11 6AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Hanley</last_name>
      <phone>+447414542237</phone>
      <email>stephaniejanehanley@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>McKinley MC, Allen-Walker V, McGirr C, Rooney C, Woodside JV. Weight loss after pregnancy: challenges and opportunities. Nutr Res Rev. 2018 Dec;31(2):225-238. doi: 10.1017/S0954422418000070. Epub 2018 Jul 9.</citation>
    <PMID>29984681</PMID>
  </reference>
  <reference>
    <citation>Dalrymple KV, Flynn AC, Relph SA, O'Keeffe M, Poston L. Lifestyle Interventions in Overweight and Obese Pregnant or Postpartum Women for Postpartum Weight Management: A Systematic Review of the Literature. Nutrients. 2018 Nov 7;10(11):1704. doi: 10.3390/nu10111704.</citation>
    <PMID>30405088</PMID>
  </reference>
  <reference>
    <citation>Dodd JM, Deussen AR, O'Brien CM, Schoenaker DAJM, Poprzeczny A, Gordon A, Phelan S. Targeting the postpartum period to promote weight loss: a systematic review and meta-analysis. Nutr Rev. 2018 Aug 1;76(8):639-654. doi: 10.1093/nutrit/nuy024.</citation>
    <PMID>29889259</PMID>
  </reference>
  <reference>
    <citation>Guo J, Chen JL, Whittemore R, Whitaker E. Postpartum Lifestyle Interventions to Prevent Type 2 Diabetes Among Women with History of Gestational Diabetes: A Systematic Review of Randomized Clinical Trials. J Womens Health (Larchmt). 2016 Jan;25(1):38-49. doi: 10.1089/jwh.2015.5262. Epub 2015 Dec 24.</citation>
    <PMID>26700931</PMID>
  </reference>
  <reference>
    <citation>Burke LE, Wang J, Sevick MA. Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc. 2011 Jan;111(1):92-102. doi: 10.1016/j.jada.2010.10.008.</citation>
    <PMID>21185970</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nottingham Trent University</investigator_affiliation>
    <investigator_full_name>Stephanie Hanley</investigator_full_name>
    <investigator_title>Miss</investigator_title>
  </responsible_party>
  <keyword>Postpartum, Overweight, Obesity, Exercise, Diet, Lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual participant data may be made available to other researchers following completion of the current trial in an anonymised/pseudonymised format to prevent individual participant identification. Data will be provided in response to certain requests (e.g. if a systematic review and meta-analysis/statistical power calculation is being conducted that requires access to certain raw data).</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03826394
org study id: NottinghamTU
nct id: NCT03826394
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The current study aims to investigate the effects of a chosen technology-based exercise or
      healthy eating intervention that combines individual and group-based support, on weight loss
      and other health-related parameters in postpartum women with overweight or obesity. All
      participants will be asked to engage in a 20-week programme consisting of a 4 week tracked
      free living period followed by a 16-week intervention. The investigators hypothesise that
      reductions in BMI (body mass index) and improvements in health-related parameters will be
      observed post-intervention.
The current study will investigate the effects of a chosen exercise or dietary intervention
      on BMI and other health-related parameters in postpartum women with overweight and obesity.
      Dietary or physical activity interventions, alone or combined, are associated with greater
      weight loss when provided to women in the postpartum period, compared with no intervention.
      Providing a combined physical activity and dietary intervention is associated with an average
      weight loss of 2.49kg post-intervention and 2.4kg 12 months after pregnancy. However, the
      variation in average weight loss achieved is great which could be due to differences in the
      design of lifestyle programmes.

      Interventions including individualised support and self-monitoring have proven more effective
      in promoting reductions in BMI in postpartum women. However, high levels of attrition and
      poor engagement have been highlighted as two areas that require attention in this area.
      Therefore, future research is required to identify strategies best suited to the design and
      implementation of effective lifestyle interventions in overweight and obese postpartum women.

      Women between six weeks and one year postpartum will elect to be part of either a 16-week
      exercise or dietary intervention. Prior to this, participants will be tracked for a period of
      four weeks in free living conditions. Each intervention will be split into four blocks of
      three weeks where staged intervention specific information will be provided. Individualised
      face-to-face and technological group support will be provided throughout. For the final four
      weeks of the intervention no new information will be provided and all support will be
      withdrawn.

      Analyses of body composition and girths, blood metabolites, resting heart rate, blood
      pressure, and questionnaires assessing physical activity, eating behaviours and quality of
      life will be carried out alongside assessments of BMI at baseline, pre-intervention and at
      both twelve and sixteen weeks of the intervention. Measures of BMI, resting heart rate, blood
      pressure and questionnaire scores will be taken at each three weekly stage of the
      intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants will take part in an exercise or dietary intervention in a non-randomised, parallel study.
Each intervention will be preceded by a four week tracked free-living period. Both interventions will be completed over a sixteen week period. Following the tracked period, participants will choose to take part in either the exercise or dietary intervention. Intervention information will be delivered in four, three week blocks. No new information will be provided during the final four weeks of the intervention.
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in BMI
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Weight (kg) and height (m) will be combined to report BMI in kg/m^2
measure: Change in Body Composition
time frame: Week 0, 4, 16, 20
description: Whole body DXA (dual energy X-ray absorptiometry) scan to assess fat mass, fat-free mass, bone density.
measure: Change in Blood Metabolites
time frame: Week 0, 4, 16, 20
description: Fingertip blood sample taken to assess total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glycated haemoglobin, random glucose.
measure: Change in Body Girths
time frame: Week 0, 4, 16, 20
description: Measures (in cm) of waist, hip, thigh, calf, bust and upper arm girths.
measure: Change in Blood Pressure
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Measure of blood pressure taken at rest.
measure: Change in Resting Heart Rate
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Measure of heart rate taken at rest.
measure: Change in Quality of Life
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Assessment of quality of life using the Impact of Weight on Quality on Life (Lite) and Short-Form 36 Questionnaires.
Short-Form 36- scores range from 0-100 (lower scores= more disability; higher scores = less disability).
Impact of Weight on Quality of Life- 31-item that calculates a total score and scores on 5 separate domains (physical function, self-esteem, sexual life, public distress, work).
measure: Change in Sleep Quality
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Assessment of sleep quality using Pittsburgh Sleep Quality Index Questionnaire. Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate. Only self-rated questions are included in the scoring. Self-rated items are combined to form 7 component scores, each of which has a range of 0-3 points. A score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The 7 components scores are then summed together to yield one global score, with a range of 0-21 points. 0 indicates no difficulty and 21 indicates severe difficulties in all areas.
measure: Change in Eating Behaviours
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Assessment of eating behaviours using Three Factor Eating Questionnaire. Responses to each of the 18 items are given a score of between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
measure: Change in Physical Activity Levels
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Measures of physical activity levels through direct (Fitbit) and indirect (Godin 7-day leisure time physical activity questionnaire) measures.
measure: Change in Markers of Postnatal Depression
time frame: Week 0, 4, 7, 10, 13, 16, 20
description: Assessment of markers of depression using Edinburgh Postnatal Depression Scale. Responses to each of the 10 items are given a score of 0 to 3. The maximum score is 30. Higher scores indicate greater degrees of depression, with a score of 13 or above indicating varying degrees of depressive illness.
arm group label: Exercise Intervention
arm group type: Experimental
description: Exercise intervention with the aim of incrementally increasing physical activity to meet the national recommendation of 150 minutes a week of moderate-vigorous physical activity, reducing BMI and improving overall health.
arm group label: Dietary Intervention
arm group type: Experimental
description: Staged dietary intervention with the aim of improving eating behaviours, reducing BMI and improving overall health.
intervention type: Behavioral
intervention name: Exercise Intervention
description: Education based sixteen week intervention where participants will be provided with core information every three weeks and supplementary information through technological means at other time points. All provided information will be exercise specific. Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks. Fitbit Flex 2 provided for the duration of the study.
arm group label: Exercise Intervention
other name: Physical Activity Intervention
intervention type: Behavioral
intervention name: Dietary Intervention
description: Education based sixteen week intervention where participants will be provided with core information every three weeks and supplementary information through technological means at other time points. All provided information will be diet specific. Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks. Fitbit Flex 2 provided for the duration of the study.
arm group label: Dietary Intervention
other name: Nutritional Intervention/Healthy eating Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Stephanie J Hanley, MRes
role: Principal Investigator
affiliation: Nottingham Trent University
last name: Stephanie J Hanley, MRes
phone: 07414542237
email: stephanie.hanley2016@my.ntu.ac.uk
last name: Kirsty J Elliott-Sale, PhD
phone: 01158486338
email: kirsty.elliottsale@ntu.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: McKinley MC, Allen-Walker V, McGirr C, Rooney C, Woodside JV. Weight loss after pregnancy: challenges and opportunities. Nutr Res Rev. 2018 Dec;31(2):225-238. doi: 10.1017/S0954422418000070. Epub 2018 Jul 9.
PMID: 29984681
citation: Dalrymple KV, Flynn AC, Relph SA, O'Keeffe M, Poston L. Lifestyle Interventions in Overweight and Obese Pregnant or Postpartum Women for Postpartum Weight Management: A Systematic Review of the Literature. Nutrients. 2018 Nov 7;10(11):1704. doi: 10.3390/nu10111704.
PMID: 30405088
citation: Dodd JM, Deussen AR, O'Brien CM, Schoenaker DAJM, Poprzeczny A, Gordon A, Phelan S. Targeting the postpartum period to promote weight loss: a systematic review and meta-analysis. Nutr Rev. 2018 Aug 1;76(8):639-654. doi: 10.1093/nutrit/nuy024.
PMID: 29889259
citation: Guo J, Chen JL, Whittemore R, Whitaker E. Postpartum Lifestyle Interventions to Prevent Type 2 Diabetes Among Women with History of Gestational Diabetes: A Systematic Review of Randomized Clinical Trials. J Womens Health (Larchmt). 2016 Jan;25(1):38-49. doi: 10.1089/jwh.2015.5262. Epub 2015 Dec 24.
PMID: 26700931
citation: Burke LE, Wang J, Sevick MA. Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc. 2011 Jan;111(1):92-102. doi: 10.1016/j.jada.2010.10.008.
PMID: 21185970
responsible party type: Principal Investigator
investigator affiliation: Nottingham Trent University
investigator full name: Stephanie Hanley
investigator title: Miss
mesh term: Overweight
sharing ipd: Undecided
ipd description: Individual participant data may be made available to other researchers following completion of the current trial in an anonymised/pseudonymised format to prevent individual participant identification. Data will be provided in response to certain requests (e.g. if a systematic review and meta-analysis/statistical power calculation is being conducted that requires access to certain raw data).