Trial of Fresh Start Weight Loss Intervention in WIC Participants

University of Massachusetts, Worcester

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Group program; Behavioral: Print Materials

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02176915

P60MD006912 (U.S. NIH Grant/Contract)

1P60MD006912

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Group program

Experimental group

Description:

8-session group weight loss program and 4 follow-up phone counseling sessions

Treatment:

Behavioral: Group program

Print Materials

Active Comparator group

Description:

8 weekly mailings of print materials covering weight loss topics through US mail.

Treatment:

Behavioral: Print Materials