ObesityPhase 2/3NCT01211574
Pilot Study Testing Professional, Peer, and Mentor Health Coaches for Weight Loss
A Phase 2/3 study testing peer coach, mentor and Professional in people with Obesity, run by The Miriam Hospital.
Trial summary
Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or Professionals. The aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- peer coach, mentor and Professional
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Apr 2011
- Phase
- Phase 2/3
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 40-60
Who cannot join
- Participants will be excluded if they:
- Are unwilling to participate in a weight control program that includes weight coaches.
- Report not being able to walk 2 blocks (1/4 mile) without stopping.
- Are participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months.
- Are pregnant, lactating, less than 6 months post-partum or plan to become pregnant during the time of the intervention.
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Participants reporting joint problems, medication use, or other medical conditions that may limit their ability to exercise will be required to obtain written permission from their physician to participate in the intervention.
- Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, bulimia nervosa, dementia, or severe psychiatric condition).
About this study
Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or Professionals. The aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss.
- Conditions
- Obesity
- Being tested
- peer coach, mentor, Professional
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer coachBehavioural
Participants will receive behavioral weight loss treatment and be coached by a peer between treatment visits.
mentorBehavioural
Participants will receive behavioral weight loss treatment and be coached by a mentor between treatment visits.
ProfessionalBehavioural
Participants will receive behavioral weight loss treatment and be coached by a behavioral weight loss interventionist between treatment visits.
| Study group | Role | What they receive |
|---|---|---|
| peer coach | Experimental | Participants will be coached by a peer between treatment visits. Receives: Behavioral: peer coach |
| mentor | Experimental | Participants will be coached by a mentor between treatment visits Receives: Behavioral: mentor |
| Professional | Experimental | Participants will be coached by an interventionist between treatment visits Receives: Behavioral: Professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tricia M. Leahey, Ph.D., The Miriam Hospital
- Investigators
- Tricia M Leahey, PhD, Principal investigator, The Miriam Hospital / Warren Alpert Medical School at Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211574
- Sponsor's protocol ID
- 2044-10
- Status last verified
- Jul 2012
- First submitted
- 28 Sep 2010
- Last updated
- 13 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Testing Professional, Peer, and Mentor Health Coaches for Weight Loss
- ClinicalTrials.gov ID
- NCT01211574
- Acronym / sponsor ID
- 2044-10
- Conditions
- Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Sep 2010 (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.
Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or Professionals. The aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| peer coach | Experimental | Behavioral: peer coachParticipants will be coached by a peer between treatment visits. |
| mentor | Experimental | Behavioral: mentorParticipants will be coached by a mentor between treatment visits |
| Professional | Experimental | Behavioral: ProfessionalParticipants will be coached by an interventionist between treatment visits |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 40-60
Key exclusion criteria (7 listed)
- Participants will be excluded if they:
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 |
|---|---|---|
| peer coachParticipants will receive behavioral weight loss treatment and be coached by a peer between treatment visits. | Behavioural | peer coach |
| mentorParticipants will receive behavioral weight loss treatment and be coached by a mentor between treatment visits. | Behavioural | mentor |
| ProfessionalParticipants will receive behavioral weight loss treatment and be coached by a behavioral weight loss interventionist between treatment visits. | Behavioural | Professional |
Primary outcome
weight change
Time frame: 0 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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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.
Tricia M Leahey, PhD principal investigator
The Miriam Hospital / Warren Alpert Medical School at Brown University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing peer coach, mentor and Professional in people with Obesity, run by The Miriam Hospital.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weight change (time frame: 0 to 6 months). 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 13 Jul 2012.