This trial is active, not recruiting.

Condition obesity
Treatments group program, print materials
Sponsor University of Massachusetts, Worcester
Start date July 2014
End date June 2017
Trial size 139 participants
Trial identifier NCT02176915, 1P60MD006912


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
8-session group weight loss program and 4 follow-up phone counseling sessions
group program
(Active Comparator)
8 weekly mailings of print materials covering weight loss topics through US mail.
print materials

Primary Outcomes

Change in Body Mass Index from baseline
time frame: 3 months, 12 months

Secondary Outcomes

Change in Pregnancy Physical Activity Questionnaire score from baseline
time frame: 3 months, 12 months
Change in 24-hour dietary recall from baseline
time frame: 3 months, 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Fresh Start: A Randomized Clinical Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Massachusetts, Worcester.