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Completed

NCT Number: NCT02251587

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 month–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Weight Management Program

Other

Standard Diet program based on diet and exercise.

Sensible Weigh Program

Other

Weight loss program designed for low income women.

Primary outcomes

  1. Feasibility of implementing weight management program

    Time frame: 9 Months

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

Secondary outcomes

  1. Change in weight

    Time frame: Change from Baseline to Month 3

    Change in weight during the weight loss phase

  2. Change in weight

    Time frame: Change from Month 3 to Month 9

    Change in weight during the weight management phase

  3. Change in diet quality

    Time frame: Change from Baseline to Month 3

    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.

  4. Change in diet quality

    Time frame: Change from Month 3 to Month 9

    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.

  5. Change in food security status

    Time frame: Change from Baseline to Month 3

    Change during the weight loss phase. Change will be measured based upon responses to the US Household Food Security Questionnaire

  6. Change in food security status

    Time frame: Change from Month 3 to Month 9

    Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire

Sponsors and collaborators

Lead sponsor

Jeannine Goetz, PhD

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2014
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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