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Completed

NCT Number: NCT02176915

Trial of Fresh Start Weight Loss Intervention in WIC Participants

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMass Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group program

Behavioral

print materials

Behavioral

Primary outcomes

  1. Change in Body Mass Index from baseline

    Time frame: 3 months, 12 months

Secondary outcomes

  1. Change in Pregnancy Physical Activity Questionnaire score from baseline

    Time frame: 3 months, 12 months

  2. Change in 24-hour dietary recall from baseline

    Time frame: 3 months, 12 months

    Dietary behavior will be measured using a 24-hour dietary recall.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Fresh Start: A Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jun 27, 2014
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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