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Comadres Weight Loss Pilot Program

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comadres Weight Loss Pilot Program
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Social Support

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women who self-identify as Hispanic or Latino
  • Rhode Island resident
  • Overweight or obese (BMI 27-50 kg/m2)
  • Ages 18-65 years old
  • English speaking & literate
  • If randomized to the comadre condition, the participant's comadre must also meet all inclusion and exclusion criteria and must not reside in the same household.

Exclusion Criteria:

  • Pregnant, lactating, less than 6 months post-partum, or plans to become pregnant in the next 6 months
  • Currently participating in another weight loss program, taking weight loss medication, and/or lost ≥ 10% of body weight during the past 6 months
  • Reports being unable to walk 2 blocks (1/4 mile) without stopping
  • Reports a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, & Shepard, 1992), which will be administered during the phone screen.
  • Individuals with medical conditions that could limit exercise will be required to obtain written physician consent to participate
  • Reports conditions that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol for the study period including terminal illness, plans to relocate, substance abuse, eating disorder, or significant psychiatric problems

Sites / Locations

  • Weight Control and Diabetes Research Center, The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Comadre Treatment

Non Support Partner Treatment

Outcomes

Primary Outcome Measures

Participant Recruitment and Retention

Secondary Outcome Measures

Full Information

First Posted
July 18, 2008
Last Updated
February 5, 2009
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00719927
Brief Title
Comadres Weight Loss Pilot Program
Official Title
Comadres Weight Loss Pilot Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Miriam Hospital

4. Oversight

5. Study Description

Brief Summary
Latinas are more likely to be obese and physically inactive than white women. Therefore, a behavioral weight loss program for Latinas will be tested in this pilot study. Thirty overweight or obese Latinas will be recruited for a 12 week weight loss program at the Weight Control & Diabetes Research Center. Participants will be provided with nutrition and physical activity education and be taught behavioral skills to help them adopt lifestyle changes that produce weight loss. Participants will be placed on a reduced calorie diet and instructed to gradually increase their level of physical activity. To encourage participants to monitor their daily eating and exercise activities, participants will be instructed to record these activities in food and exercise diaries and submit them each week. Two treatment groups will be tested. The first group will have participants attend sessions with a female friend (comadre). The second group will have participants attend sessions without a comadre. The aims of this study are to determine whether we can succeed in recruiting Latinas with their comadres and whether we can reduce participant drop-out by having Latinas participate with their comadres in a behavioral weight loss program.
Detailed Description
National studies indicate a need for behavioral treatments for Latinas that promote recommended weight loss and weight loss maintenance practices. In the national Behavioral Risk Factor Surveillance System survey, Latinas were found to be more likely to attempt weight loss than white or black females. However, they were least likely to follow the recommendations of consuming less calories and exercising at least 150 minutes per week. In fact, Latinas more than whites reported using fasting or diet pills as a method of weight control. Furthermore, participating in organized weight loss programs was less common among Latinas than whites. Hence, a weight control intervention aimed at helping Latinas develop the behavioral skills shown to promote weight loss and weight loss maintenance is warranted. We propose to recruit 30 overweight or obese adult Latinas and randomly assign them to one of two conditions. Both conditions will offer 12 weekly group sessions involving a standard behavioral treatment. Behavioral techniques will be taught for the promotion of weight loss via adherence to a reduced caloric diet and increased physical activity. The first condition will consist of women participating with a female friend (comadre), while the second condition will consist of women participating without a support partner. An intervention strategy in which women participate in a behavioral weight loss program with a comadre will be evaluated in terms of participant recruitment and retention in this pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Social Support

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Comadre Treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non Support Partner Treatment
Intervention Type
Behavioral
Intervention Name(s)
Comadres Weight Loss Pilot Program
Other Intervention Name(s)
Support Partner, Non Support Partner
Intervention Description
The first condition will consist of women participating with a female friend (comadre), while the second condition will consist of women participating without a support partner.
Primary Outcome Measure Information:
Title
Participant Recruitment and Retention
Time Frame
Sept 2008-March 2009

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who self-identify as Hispanic or Latino Rhode Island resident Overweight or obese (BMI 27-50 kg/m2) Ages 18-65 years old English speaking & literate If randomized to the comadre condition, the participant's comadre must also meet all inclusion and exclusion criteria and must not reside in the same household. Exclusion Criteria: Pregnant, lactating, less than 6 months post-partum, or plans to become pregnant in the next 6 months Currently participating in another weight loss program, taking weight loss medication, and/or lost ≥ 10% of body weight during the past 6 months Reports being unable to walk 2 blocks (1/4 mile) without stopping Reports a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, & Shepard, 1992), which will be administered during the phone screen. Individuals with medical conditions that could limit exercise will be required to obtain written physician consent to participate Reports conditions that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol for the study period including terminal illness, plans to relocate, substance abuse, eating disorder, or significant psychiatric problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center, The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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