CClinicalTrials.gg
CompletedNCT02251587Updated Feb 3, 2016

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

An interventional study of Standard Weight Management Program and Sensible Weigh Program in Weight Loss, sponsored by Jeannine Goetz, PhD. Completed at 1 site in United States. Open to female participants aged 21 Months to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-03.

Sponsored by Jeannine Goetz, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
21 Months to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Weight Loss
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 28 is below the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

This is the only study on the registry with Jeannine Goetz, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Months to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherStandard Weight Management Program

    Standard Diet program based on diet and exercise.

  • OtherSensible Weigh Program

    Weight loss program designed for low income women.

06

What researchers measure

Primary outcomes

  1. Feasibility of implementing weight management program

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

    Time frame: 9 Months

Secondary outcomes

  1. Change in weight

    Change in weight during the weight loss phase

    Time frame: Change from Baseline to Month 3

  2. Change in weight

    Change in weight during the weight management phase

    Time frame: Change from Month 3 to Month 9

  3. 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.

    Time frame: Change from Baseline to Month 3

  4. 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.

    Time frame: Change from Month 3 to Month 9

  5. 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

    Time frame: Change from Baseline to Month 3

  6. 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

    Time frame: Change from Month 3 to Month 9

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02251587
Lead sponsor
Jeannine Goetz, PhD
Responsible party
Jeannine Goetz, PhD (Assistant Professor, University of Kansas Medical Center) — Sponsor-investigator
First posted
Sep 29, 2014
Start date
Sep 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 3, 2016

Study contacts

Jeannine Goetz, PhD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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