Lifestyle Interventions in Overweight and Obese Postpartum Women

NCT ID: NCT03826394

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2020-02-29

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

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.

Dietary Intervention

Staged dietary intervention with the aim of improving eating behaviours, reducing BMI and improving overall health.

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Exercise Intervention

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.

Intervention Type: BEHAVIORAL

Dietary Intervention

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical Activity Intervention; Nutritional Intervention/Healthy eating 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nottingham Trent University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Hanley

Miss

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie J Hanley, MRes

Role: PRINCIPAL_INVESTIGATOR

Nottingham Trent University

Locations

Nottingham Trent University, Clifton Campus

Nottingham, Nottinghamshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Stephanie J Hanley, MRes

Role: CONTACT

stephanie.hanley2016@my.ntu.ac.uk

07414542237

Kirsty J Elliott-Sale, PhD

Role: CONTACT

kirsty.elliottsale@ntu.ac.uk

01158486338

Facility Contacts

Stephanie Hanley

Role: primary

stephaniejanehanley@hotmail.com

+447414542237

References

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.

Reference Type: BACKGROUND

PMID: 29984681 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30405088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29889259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26700931 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21185970 (View on PubMed)

Other Identifiers

NottinghamTU

Identifier Type: -

Identifier Source: org_study_id