The $Ensible Weight Program: An Intervention Tailored for Low Income Women

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Other: Standard Weight Management Program; Other: Sensible Weigh Program

• Registration Number: NCT02251587
• Lead Sponsor: Jeannine Goetz, PhD

Brief Summary

The purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program.

Detailed Description

Low income women are at greater risk of both obesity and food insecurity (not having consistent access to nutritious and adequate amounts of food). Most weight loss programs targeted at low income women do not focus on gaining skills and knowledge to reduce food insecurity.

Eligible participants will be randomized into one of two groups. The two groups will follow different weight management programs. One group will follow a standard weight management program. The other group with follow the investigations program, the $ensible Weigh Program. Participation in the study will last about 9 months.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Documented low income
• Body Mass Index (BMI) >25.0 kg/m2
• Must speak and understand English
• Able to attend intervention sessions and have access to telephone

Exclusion Criteria

• Report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac event
• Currently or planning to become pregnant during the intervention
• Have no control over food purchases or choices
• Report participation in a weight reduction program involving diet or PA within past 6 months
• Report symptomology of an eating disorder
• Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, Atkins, macrobiotic, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Weight Management Program	Standard Weight Management Program	Participants will be given information on diet and exercise. Participants will attend meetings to discuss barriers to exercise and nutrition and ways to solve these problems. Participants will be given healthy snack ideas and planning tools.
$ensible Weigh Program	Sensible Weigh Program	Participants will be given information on diet and exercise with an emphasis on food security. Participants will be provided with additional information on community resources such as those for food, transportation, and safe places to exercise. A weekly cooking demonstration will be provided using inexpensive ingredients and common food pantry items.

Primary Outcome Measures

Name	Time	Method
Feasibility of implementing weight management program	9 Months	Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.

Secondary Outcome Measures

Name	Time	Method
Change in weight	Change from Month 3 to Month 9	Change in weight during the weight management phase
Change in diet quality	Change from Month 3 to Month 9	Change during the weight management phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.
Change in food security status	Change from Month 3 to Month 9	Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States