Trial of Fresh Start Weight Loss Intervention in WIC Participants

Fresh Start: A Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02176915

Enrollment

139

Registered

2014-06-27

Start date

2014-07-31

Completion date

2019-09-30

Last updated

2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALPrint Materials

BEHAVIORALGroup program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Body Mass Index from baseline	3 months, 12 months

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026