ObesityNCT00719927
Comadres Weight Loss Pilot Program
A study testing Comadres Weight Loss Pilot Program in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Comadres Weight Loss Pilot Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center, The Miriam Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Comadres Weight Loss Pilot Program
- Keywords
- Social Support
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comadres Weight Loss Pilot ProgramBehavioural
Also called Support Partner, Non Support Partner
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Comadre Treatment Receives: Behavioral: Comadres Weight Loss Pilot Program |
| 2 | Active comparator | Non Support Partner Treatment Receives: Behavioral: Comadres Weight Loss Pilot Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment and Retention
Measured: Sept 2008-March 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Rena Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719927
- Sponsor's protocol ID
- 2040-08
- Status last verified
- Jun 2008
- First submitted
- 18 Jul 2008
- Last updated
- 6 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comadres Weight Loss Pilot Program
- ClinicalTrials.gov ID
- NCT00719927
- Acronym / sponsor ID
- 2040-08
- Conditions
- Obesity
- Keywords
- Social Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Comadres Weight Loss Pilot ProgramComadre Treatment |
| 2 | Active comparator | Behavioral: Comadres Weight Loss Pilot ProgramNon Support Partner Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comadres Weight Loss Pilot ProgramAlso: Support Partner, Non Support PartnerThe 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. | Behavioural | 1, 2 |
Primary outcome
Participant Recruitment and Retention
Time frame: Sept 2008-March 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena Wing, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comadres Weight Loss Pilot Program in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment and Retention (time frame: Sept 2008-March 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.