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

NCT ID: NCT02251587

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Weight Management Program

Intervention Type: OTHER

Standard Diet program based on diet and exercise.

$ensible 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.

Group Type: EXPERIMENTAL

Sensible Weigh Program

Intervention Type: OTHER

Weight loss program designed for low income women.

Interventions

Standard Weight Management Program

Standard Diet program based on diet and exercise.

Intervention Type: OTHER

Sensible Weigh Program

Weight loss program designed for low income women.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Months
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jeannine Goetz, PhD

OTHER

Sponsor Role: lead

Responsible Party

Jeannine Goetz, PhD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeannine Goetz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00001503

Identifier Type: -

Identifier Source: org_study_id