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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251587
• Other study ID #: STUDY00001503
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: February 2, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Months to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Loss

Intervention

Other:
• Standard Weight Management Program
Standard Diet program based on diet and exercise.
• Sensible Weigh Program
Weight loss program designed for low income women.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Jeannine Goetz, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementing weight management program	Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.	9 Months	No
Secondary	Change in weight	Change in weight during the weight loss phase	Change from Baseline to Month 3	No
Secondary	Change in weight	Change in weight during the weight management phase	Change from Month 3 to Month 9	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No