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

NCT02251587 | Completed

• 1 other identifier: STUDY00001503
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing weight management program

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

  9 Months

Secondary Outcomes (6)

• Change in weight

  Change from Baseline to Month 3

• Change in weight

  Change from Month 3 to Month 9

• Change in diet quality

  Change from Baseline to Month 3

• Change in diet quality

  Change from Month 3 to Month 9

• Change in food security status

  Change from Baseline to Month 3

Study Arms (2)

Standard Weight Management Program

ACTIVE COMPARATOR

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

$ensible Weigh Program

EXPERIMENTAL

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

Standard Weight Management Program OTHER

Standard Diet program based on diet and exercise.

Standard Weight Management Program

Sensible Weigh Program OTHER

Weight loss program designed for low income women.

$ensible Weigh Program

Eligibility Criteria

• Age: 21 Months - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeannine Goetz, PhD: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeannine Goetz, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (1)