search
Back to results

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

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Weight Management Program
Sensible Weigh Program
Sponsored by
Jeannine Goetz, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

21 Months - 65 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Weight Management Program

$ensible Weigh Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of implementing weight management program
Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.

Secondary Outcome Measures

Change in weight
Change in weight during the weight loss phase
Change in weight
Change in weight during the weight management phase
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 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 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 in food security status
Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire

Full Information

First Posted
September 25, 2014
Last Updated
February 2, 2016
Sponsor
Jeannine Goetz, PhD
search

1. Study Identification

Unique Protocol Identification Number
NCT02251587
Brief Title
The $Ensible Weight Program: An Intervention Tailored for Low Income Women
Official Title
The $Ensible Weight Program: An Intervention Tailored for Low Income Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeannine Goetz, PhD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Weight Management Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
$ensible Weigh Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Weight Management Program
Intervention Description
Standard Diet program based on diet and exercise.
Intervention Type
Other
Intervention Name(s)
Sensible Weigh Program
Intervention Description
Weight loss program designed for low income women.
Primary Outcome Measure Information:
Title
Feasibility of implementing weight management program
Description
Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Change in weight
Description
Change in weight during the weight loss phase
Time Frame
Change from Baseline to Month 3
Title
Change in weight
Description
Change in weight during the weight management phase
Time Frame
Change from Month 3 to Month 9
Title
Change in diet quality
Description
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
Title
Change in diet quality
Description
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
Title
Change in food security status
Description
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
Title
Change in food security status
Description
Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire
Time Frame
Change from Month 3 to Month 9

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannine Goetz, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs