NCT00719927

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 6, 2009

Status Verified

June 1, 2008

Enrollment Period

9 months

First QC Date

July 18, 2008

Last Update Submit

February 5, 2009

Conditions

Obesity

Keywords

Social Support

Outcome Measures

Primary Outcomes (1)

  • Participant Recruitment and Retention

    Sept 2008-March 2009

Study Arms (2)

1

EXPERIMENTAL

Comadre Treatment

Behavioral: Comadres Weight Loss Pilot Program

2

ACTIVE COMPARATOR

Non Support Partner Treatment

Behavioral: Comadres Weight Loss Pilot Program

Interventions

Comadres Weight Loss Pilot ProgramBEHAVIORAL

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.

Also known as: Support Partner, Non Support Partner
12

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center, The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rena Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 6, 2009

Record last verified: 2008-06

Locations

US(1)