Trial of Fresh Start Weight Loss Intervention in WIC Participants

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02176915
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

Detailed Description

The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.

Study Timeline

• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Study Start: 2014-07
• Primary Completion: 2018-12
• Study Completion: 2019-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

Inclusion Criteria

• 6 months or less postpartum
• Speaks English
• BMI 25 or greater
• Client of WIC program, Worcester MA

Exclusion Criteria

• Not able to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index from baseline	3 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Pregnancy Physical Activity Questionnaire score from baseline	3 months, 12 months
Change in 24-hour dietary recall from baseline	3 months, 12 months	Dietary behavior will be measured using a 24-hour dietary recall.

Trial Locations

Locations (1)

UMass Medical School; 🇺🇸 Worcester, Massachusetts, United States