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

Jeannine Goetz, PhD28 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Weight Loss

Interventions

Standard Weight Management ProgramOTHER

Standard Diet program based on diet and exercise.

Sensible Weigh ProgramOTHER

Weight loss program designed for low income women.

Eligibility

Sex: FEMALEMin age: 21 MonthsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Feasibility of implementing weight management program

Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.

Time frame: 9 Months

Secondary Outcomes

Change in weight

Change in weight during the weight loss phase

Time frame: Change from Baseline to Month 3

Change in weight

Change in weight during the weight management phase

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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