Clinical trial NCT03826394: Lifestyle Interventions in Overweight and Obese Postpartum Women
Official title: The Effects of Exercise and Dietary Interventions in Overweight and Obese Postpartum Women on Weight Management and Health.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: Postpartum, Overweight, Obesity, Exercise, Diet, Lifestyle
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Be at least 18 years old at the date of their first visit. Have a body mass index (BMI) of greater than 25 kg∙m2 (this will be worked out by the researchers using the participant's height and body weight). Have had a singleton pregnancy. Have had one pregnancy to date. Be 6 weeks-1 year postpartum (and had physician's approval to return to exercise).

Own a smartphone (able to download and use WhatsApp). In the researcher's opinion, the participant is able and willing to follow all trial requirements.

Exclusion Criteria:

Have a clinical diagnosis of depression/postnatal depression. Currently enrolled on another weight loss programme. Currently consuming weight loss tablets/supplements. Have heart/liver/chronic renal disease. Have a clinical diagnosis of Type 2 Diabetes Mellitus. Consume excessive amounts of alcohol (regularly drinking more than 14 units of alcohol a week). Actively trying for another baby/planning a pregnancy in the next 6 months. Experienced a stillbirth. Have any health conditions that affect physical activity engagement. On any medication that affects the ability to exercise. On any medication that affects the ability to follow a healthy eating programme.

Primary outcomes:
measure: Changes in BMI
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
Secondary outcomes:
measure: Change in Body Composition
timeFrame: Week 0, 4, 16, 20
measure: Change in Blood Metabolites
timeFrame: Week 0, 4, 16, 20
measure: Change in Body Girths
timeFrame: Week 0, 4, 16, 20
measure: Change in Blood Pressure
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
measure: Change in Resting Heart Rate
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
measure: Change in Quality of Life
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
measure: Change in Sleep Quality
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
measure: Change in Eating Behaviours
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
measure: Change in Physical Activity Levels
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
measure: Change in Markers of Postnatal Depression
timeFrame: Week 0, 4, 7, 10, 13, 16, 20
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University, Clifton Campus
state: Nottinghamshire
Study officials:
affiliation: Nottingham Trent University
name: Stephanie J Hanley, MRes
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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.