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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Loss

Intervention / Treatment
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* Other: Standard Weight Management Program
* Other: Sensible Weigh Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Months
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Weight Management Program<br>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. | Other: Standard Weight Management Program<br>* Standard Diet program based on diet and exercise.<br>|
| Experimental: $ensible Weigh Program<br>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. | Other: Sensible Weigh Program<br>* Weight loss program designed for low income women.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of implementing weight management program | Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction. | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Change in weight during the weight loss phase | Change from Baseline to Month 3 | 
| Change in weight | Change in weight during the weight management phase | Change from Month 3 to Month 9 | 
| Change in diet quality | Change during the weight loss 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 from Baseline to Month 3 | 
| Change in diet quality | 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 from Month 3 to Month 9 | 
| Change in food security status | Change during the weight loss phase. Change will be measured based upon responses to the US Household Food Security Questionnaire | Change from Baseline to Month 3 | 
| Change in food security status | Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire | Change from Month 3 to Month 9 |