Lifestyle Interventions in Overweight and Obese Postpartum Women

NCT03826394 | Unknown

• 1 other identifier: NottinghamTU
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Postpartum, Overweight, Obesity, Exercise, Diet, Lifestyle

Outcome Measures

Primary Outcomes (1)

• Changes in BMI

  Weight (kg) and height (m) will be combined to report BMI in kg/m\^2

  Week 0, 4, 7, 10, 13, 16, 20

Secondary Outcomes (10)

• Change in Body Composition

  Week 0, 4, 16, 20

• Change in Blood Metabolites

  Week 0, 4, 16, 20

• Change in Body Girths

  Week 0, 4, 16, 20

• Change in Blood Pressure

  Week 0, 4, 7, 10, 13, 16, 20

• Change in Resting Heart Rate

  Week 0, 4, 7, 10, 13, 16, 20

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Exercise Intervention

Dietary Intervention

EXPERIMENTAL

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

Behavioral: Dietary Intervention

Interventions

Exercise Intervention 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 Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks.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.

Also known as: Physical Activity Intervention

Exercise Intervention

Dietary Intervention 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.

Also known as: Nutritional Intervention/Healthy eating Intervention

Dietary Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham Trent University: lead

Study Sites (1)

Nottingham Trent University, Clifton Campus

Nottingham, Nottinghamshire, NG11 6AP, United Kingdom

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Stephanie J Hanley, MRes

  Nottingham Trent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie J Hanley, MRes

CONTACT

07414542237; stephanie.hanley2016@my.ntu.ac.uk

Kirsty J Elliott-Sale, PhD

CONTACT

01158486338; kirsty.elliottsale@ntu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: August 19, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

GB (1)