Weight LossHEALTHNCT01307280
Weight Management Demonstration Project: HEALTH
A study testing RCT1, RCT2 and RCT3 in people with Weight Loss, run by RTI International at 3 sites in United States.
Trial summary
The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- RCT1, RCT2 and RCT3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,395 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2006to Dec 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- TRICARE Prime non-active-duty beneficiaries
- Body Mass Index of 25 to 50
- Living in 4 midwestern states (TRICARE region)
Who cannot join
- Not able to engage in physical activity
- Pregnant
- Body mass index greater than 50
- Body mass index less than 25
- Human immunodeficiency virus infected
- current cancer
Trial locations and contacts
3 sites in 1 country.
United States3 sites
RTI Study Center
Fairborn, Ohio, 45324
RTI International
Research Triangle Park, North Carolina, 27709
RTI Study Center
Swansea, Illinois, 62226
About this study
Official title: Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries.
A total of 1,755 participants from four Midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. Analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.
Read the detailed description
Lifestyle modification interventions that promote healthful eating habits and physical activity can be effective in producing weight losses of 4% to 9% of initial bodyweight. If maintained, this level of weight loss can reduce hypertension, high blood glucose, and elevated lipids. However, weight losses often plateau after 6 months, and weight regain begins after 12 months. Accordingly, there is interest in interventions, such as Web-based reinforcement and brief counseling to maintain weight loss over time and in the relative cost-effectiveness of program delivery modes.
Most obesity treatment programs focus on outcomes for individuals without assessing population-based cost savings. This study suggests that a broader perspective can help to identify the benefit of weight management in adult populations. Accordingly, this study assessed the cost-effectiveness of a weight management program in a population of adults served by a large health care system-the TRICARE Management Activity (TMA), the agency that manages the TRICARE health care benefits for active-duty service members, retired service members, their families, National Guard/Reserve members, and their families. The annual direct medical costs of overweight/obesity for beneficiaries enrolled in TRICARE Prime are estimated to exceed $1.1 billion. This study investigated the effectiveness and cost-effectiveness of methods to deliver a cognitive-behavioral weight loss intervention.
- Conditions
- Weight Loss
- Being tested
- RCT1, RCT2, RCT3
- Keywords
- Behavioral Weight Management Intervention, weight loss, cost-effective analysis, high blood pressure, randomized clinical trial, behavioral interventions, physical activity, dietary change, obesity
- Medical subject headings
- Weight Loss, Hypertension, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCT1Behavioural
the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
RCT2Behavioural
bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments
RCT3Behavioural
bookHEALTH, the interactive version of eHEALTH, and telephonic coaching support provided by trained health lifestyle coaches every 2 weeks alternating between a telephone call (typically 15 to 20 minutes) and a personalized e-mail. The coaches used motivational interviewing, helped participants solve problems, and reinforced their successes.
| Study group | Role | What they receive |
|---|---|---|
| Basic HEALTH | Experimental | Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention Receives: Behavioral: RCT1 |
| Interactive Internet | Experimental | Intervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments. Receives: Behavioral: RCT2 |
| Behavioral Counseling | Experimental | RCT3 included bookHEALTH, the interactive version of eHEALTH, and telephonic coaching support provided by trained health lifestyle coaches every 2 weeks alternating between a telephone call (typically 15 to 20 minutes) and a personalized e-mail. The coaches used motivational interviewing, helped participants solve problems, and reinforced their successes. Receives: Behavioral: RCT3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index BMI
Measured: change in body mass index at baseline
BMI
Measured: change in body mass index at 6 months
BMI
Measured: change in body mass index at 12 months
BMI
Measured: change in body mass index at 18 months
Secondary outcomes (1)
Blood Pressure
Measured: change in blood pressure at baseline, and 6,12,18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionDec 2009
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 Weight LossStudies 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
- 2,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Cooper Institute, University of South Carolina
- Responsible party
- Sponsor
- Investigators
- James Hersey, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307280
- Sponsor's protocol ID
- 0209792
- Other IDs
- H94002-05-C-003
- Acronym
- HEALTH
- Status last verified
- Jan 2012
- First submitted
- 22 Feb 2011
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hersey JC, Khavjou O, Strange LB, Atkinson RL, Blair SN, Campbell S, Hobbs CL, Kelly B, Fitzgerald TM, Kish-Doto J, Koch MA, Munoz B, Peele E, Stockdale J, Augustine C, Mitchell G, Arday D, Kugler J, Dorn P, Ellzy J, Julian R, Grissom J, Britt M. The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration. Prev Med. 2012 Jan;54(1):42-9. doi: 10.1016/j.ypmed.2011.09.018. Epub 2011 Oct 6.
PubMed 22001689
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
- ClinicalTrials.gov ID
- NCT01307280
- Acronym / sponsor ID
- HEALTH / 0209792
- Conditions
- Weight Loss
- Keywords
- Behavioral Weight Management Intervention, weight loss, cost-effective analysis, high blood pressure, randomized clinical trial, behavioral interventions, physical activity, dietary change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,395 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Cooper Institute, University of South Carolina
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Mar 2011 (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.
The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries.
A total of 1,755 participants from four Midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. Analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.
Detailed description
Lifestyle modification interventions that promote healthful eating habits and physical activity can be effective in producing weight losses of 4% to 9% of initial bodyweight. If maintained, this level of weight loss can reduce hypertension, high blood glucose, and elevated lipids. However, weight losses often plateau after 6 months, and weight regain begins after 12 months. Accordingly, there is interest in interventions, such as Web-based reinforcement and brief counseling to maintain weight loss over time and in the relative cost-effectiveness of program delivery modes.
Most obesity treatment programs focus on outcomes for individuals without assessing population-based cost savings. This study suggests that a broader perspective can help to identify the benefit of weight management in adult populations. Accordingly, this study assessed the cost-effectiveness of a weight management program in a population of adults served by a large health care system-the TRICARE Management Activity (TMA), the agency that manages the TRICARE health care benefits for active-duty service members, retired service members, their families, National Guard/Reserve members, and their families. The annual direct medical costs of overweight/obesity for beneficiaries enrolled in TRICARE Prime are estimated to exceed $1.1 billion. This study investigated the effectiveness and cost-effectiveness of methods to deliver a cognitive-behavioral weight loss intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic HEALTH | Experimental | Behavioral: RCT1Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention |
| Interactive Internet | Experimental | Behavioral: RCT2Intervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments. |
| Behavioral Counseling | Experimental | Behavioral: RCT3RCT3 included bookHEALTH, the interactive version of eHEALTH, and telephonic coaching support provided by trained health lifestyle coaches every 2 weeks alternating between a telephone call (typically 15 to 20 minutes) and a personalized e-mail. The coaches used motivational interviewing, helped participants solve problems, and reinforced their successes. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- TRICARE Prime non-active-duty beneficiaries
- Body Mass Index of 25 to 50
- Living in 4 midwestern states (TRICARE region)
Key exclusion criteria (6 listed)
- Not able to engage in physical activity
- Pregnant
- Body mass index greater than 50
- Body mass index less than 25
- Human immunodeficiency virus infected
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 |
|---|---|---|
| RCT1the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention | Behavioural | Basic HEALTH |
| RCT2bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments | Behavioural | Interactive Internet |
| RCT3bookHEALTH, the interactive version of eHEALTH, and telephonic coaching support provided by trained health lifestyle coaches every 2 weeks alternating between a telephone call (typically 15 to 20 minutes) and a personalized e-mail. The coaches used motivational interviewing, helped participants solve problems, and reinforced their successes. | Behavioural | Behavioral Counseling |
Primary outcome
Body Mass Index BMI
Time frame: change in body mass index at baseline
BMI
Time frame: change in body mass index at 6 months
BMI
Time frame: change in body mass index at 12 months
BMI
Time frame: change in body mass index at 18 months
1 secondary outcome
Blood Pressure
Time frame: change in blood pressure at baseline, and 6,12,18 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 26 Jan 2012.
- Derived from this study: PubMed 22001689Hersey JC, Khavjou O, Strange LB, Atkinson RL, Blair SN, Campbell S, Hobbs CL, Kelly B, Fitzgerald TM, Kish-Doto J, Koch MA, Munoz B, Peele E, Stockdale J, Augustine C, Mitchell G, Arday D, Kugler J, Dorn P, Ellzy J, Julian R, Grissom J, Britt M. The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration. Prev Med. 2012 Jan;54(1):42-9. doi: 10.1016/j.ypmed.2011.09.018. Epub 2011 Oct 6.
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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.
James Hersey, PhD principal investigator
RTI International
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RCT1, RCT2 and RCT3 in people with Weight Loss, run by RTI International at 3 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 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: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Body Mass Index BMI (time frame: change in body mass index at baseline). The study lists 4 primary outcomes in all. 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 NCT01307280, 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 26 Jan 2012.