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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Other: Standard Weight Management Program; Other: Sensible Weigh 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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jeannine Goetz, PhD
• Investigators: Principal Investigator: Jeannine Goetz, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: STUDY00001503