ObesityThink Health!NCT00959608
Think Health! A Personal Weight Management Program
A study testing Think Health! program and Basic Plus program in people with Obesity, run by University of Pennsylvania at 5 sites in United States.
Trial summary
Think Health! A Personal Weight Management Program, or "¡Vive Saludable! Un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Think Health! program and Basic Plus program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2006to May 2007
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and men
- Ages 18 to 70 years
- Body mass index > 25 kg/m2 but < 55 kg/m2 or who weigh <400 pounds.
Who cannot join
- Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
- Weight loss > 10 pounds in the previous 3 months
- Current use of weight loss medications
- Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
- Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
- Active chemo- or radiation therapy
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- Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias
- Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure
- Participants age < 18 will be excluded because we are only using adult practices and a different type of program would be needed for patients < 18, and age > 70 years will be excluded because our experience has been that a specially tailored program would be needed. As a design consideration, we wanted to decrease the heterogeneity of the program.
- Participants with a BMI > 55 kg/m2 will be excluded because they are likely to require more extensive medical and behavioral care than can be provided in this study.
- More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions.
- Final exclusion criteria will be determined in collaboration with participating primary care providers
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Penn Family Care at St. Leonard's Court
Philadelphia, Pennsylvania, 19104
PennCare- Edward S. Cooper Practice of General Internal Medicine
Philadelphia, Pennsylvania, 19104
Greenhouse Internists
Philadelphia, Pennsylvania, 19119
Einstein Community Health Associates
Philadelphia, Pennsylvania, 19120
Northeast Family Medicine
Philadelphia, Pennsylvania, 19120
About this study
Official title: Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care
Think Health! A Personal Weight Management Program, or "¡Vive Saludable! Un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. The study has a particular focus on African Americans and Latino. The design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical practice sites to their own patients. The two versions of the lifestyle weight loss program are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same PCP counseling plus additional counseling by specially trained ancillary practice staff acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month for up to 2 years).
- Conditions
- Obesity
- Being tested
- Think Health! program, Basic Plus program
- Keywords
- Weight Management in adults, Reducing Health Disparities
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Think Health! programBehavioural
Brief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2).
Basic Plus programBehavioural
15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.
| Study group | Role | What they receive |
|---|---|---|
| Basic | Active comparator | Basic program participants receive 10-15 minute PCP weight management counseling at approximately four month intervals for up to 24 months and weight management materials. Receives: Behavioral: Think Health! program |
| Basic Plus | Experimental | Half of study participants are randomly assigned to Basic Plus program, where in addition to receiving the same intervention as the Basic program participants, the Basic Plus participants also receive counseling from a lifestyle coach at the primary care provider's office (monthly in year 1 and bimonthly in year 2). Receives: Behavioral: Think Health! program; Behavioral: Basic Plus program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight, as measured at months 0, 12, 24 (or at final visit).
Measured: Up to 24 months
Secondary outcomes (1)
Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Shiriki K Kumanyika, PhD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959608
- Sponsor's protocol ID
- 804917
- Acronym
- Think Health!
- Status last verified
- Aug 2016
- First submitted
- 13 Aug 2009
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumanyika SK, Morales KH, Allison KC, Russell Localio A, Sarwer DB, Phipps E, Fassbender JE, Tsai AG, Wadden TA. Two-Year Results of Think Health! inverted exclamation markVive Saludable!: A Primary Care Weight-Management Trial. Obesity (Silver Spring). 2018 Sep;26(9):1412-1421. doi: 10.1002/oby.22258. Epub 2018 Aug 29.
PubMed 30160061
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care
- ClinicalTrials.gov ID
- NCT00959608
- Acronym / sponsor ID
- Think Health! / 804917
- Conditions
- Obesity
- Keywords
- Weight Management in adults, Reducing Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 14 Aug 2009 (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.
Think Health! A Personal Weight Management Program, or "¡Vive Saludable! Un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. The study has a particular focus on African Americans and Latino. The design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical practice sites to their own patients. The two versions of the lifestyle weight loss program are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same PCP counseling plus additional counseling by specially trained ancillary practice staff acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month for up to 2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic | Active comparator | Behavioral: Think Health! programBasic program participants receive 10-15 minute PCP weight management counseling at approximately four month intervals for up to 24 months and weight management materials. |
| Basic Plus | Experimental | Behavioral: Think Health! program, Behavioral: Basic Plus programHalf of study participants are randomly assigned to Basic Plus program, where in addition to receiving the same intervention as the Basic program participants, the Basic Plus participants also receive counseling from a lifestyle coach at the primary care provider's office (monthly in year 1 and bimonthly in year 2). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men
- Ages 18 to 70 years
- Body mass index > 25 kg/m2 but < 55 kg/m2 or who weigh <400 pounds.
Key exclusion criteria (12 listed)
- Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
- Weight loss > 10 pounds in the previous 3 months
- Current use of weight loss medications
- Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
- Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
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 |
|---|---|---|
| Think Health! programBrief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2). | Behavioural | Basic, Basic Plus |
| Basic Plus program15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention. | Behavioural | Basic Plus |
Primary outcome
Change in body weight, as measured at months 0, 12, 24 (or at final visit).
Time frame: Up to 24 months
1 secondary outcome
Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.
Time frame: Up to 24 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 17 Aug 2016.
- Derived from this study: PubMed 30160061Kumanyika SK, Morales KH, Allison KC, Russell Localio A, Sarwer DB, Phipps E, Fassbender JE, Tsai AG, Wadden TA. Two-Year Results of Think Health! inverted exclamation markVive Saludable!: A Primary Care Weight-Management Trial. Obesity (Silver Spring). 2018 Sep;26(9):1412-1421. doi: 10.1002/oby.22258. Epub 2018 Aug 29.
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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.
Shiriki K Kumanyika, PhD, MPH principal investigator
University of Pennsylvania
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Think Health! program and Basic Plus program in people with Obesity, run by University of Pennsylvania at 5 sites 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 3 inclusion and 12 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 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
Change in body weight, as measured at months 0, 12, 24 (or at final visit). (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959608, which also lists 1 linked publication.
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 17 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.