Overweight and ObesityCTLNCT01542671
Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose
A study testing Intervention in people with Overweight and Obesity, run by Memorial Hospital of Rhode Island at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/female ≥18 and <80 years old
- Available for this research project for the entire 24-month study period
- Able to read and speak English
- Can provide informed consent
Who cannot join
- Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
- Unstable psychiatric condition
- History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
- Limited physical activity by a physician to less than a brisk walk
- Another family member in the study
- Limited prescribed diet (e.g. gluten free diet)
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- Present treatment for an eating disorder
- Underwent treatment for cancer in the past 5 years
- Dialysis
- Poorly controlled diabetes (HgbA1c > 10) or hospitalized in past 6 months for poorly controlled diabetes
- Chronic steroid therapy
- Participant requesting surgical treatment of obesity or weighing over 400 lbs.
- Major surgery in the past month
- Participating in another clinical trial with regards to obesity or physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02816'
About this study
Official title: Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice
The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study. It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort. The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective. The cost of intervention will be evaluated as it relates to study replication.
Read the detailed description
The study will translate and evaluate previously successful weight loss and physical activity studies into a primary care setting in terms of efficacy and cost effectiveness. Patients are recruited by their primary care physicians office and screened for participation and contraindications by phone. A screening visit with a run-in period of food and exercise log adherence is performed. All participants have meetings with a Lifestyle Counselor to set nutritional and lifestyle goals and an introduction to weight loss techniques at baseline, 6 months, and 12 months. A structured eating plan will be given at the baseline visit. Participants at the baseline visit are randomized to either the intervention and control groups. During the first year, intervention participants will receive monthly motivational phone calls from their lifestyle counselor to assess their progress and help navigate the lifestyle changes. Food and exercise logs are reviewed frequently and written feedback give to each interventional participant. Intervention participants also receive weekly mailings focusing on weight loss, physical activity and healthy eating, and four tailored mailings based upon information gained through contact with the lifestyle counselor. Intervention participants will also receive 2 informative DVDs during the first year. Control participants receive 2 NIDDK informational handouts on weight loss. For the second year of the study focuses on maintenance. Intervention participants receive reduced mailings of 2 per month for 6 months and then once a month until the end of one year. Intervention participants receive one additional motivational phone call at 13 months if they have not reached their weight loss goal and also receive 2 more informative DVDs. The control participants will receive 3 informational NIDDK mailings. The two arms of the study will be compared using the critical outcome measures (weight loss, PA, fat calories \& vegetable/fruit servings consumed) and secondary outcome measures (waist and hip circumference,BP,Heart rate) for weight loss efficacy. We will also evaluate the cost-effectiveness for dissemination as a PCP weight loss program in addition to the overall cost-effectiveness for the participant in terms of money spent and adverse events related to the lifestyle change.
- Conditions
- Overweight and Obesity
- Being tested
- Intervention, Control
- Keywords
- lifestyle change, obesity treatment, physical activity, primary care, quality of life
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
- Lifestyle Counselor meetings at baseline, 6 months, and 12 months
- Structured eating plan
- Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24.
- Monthly Motivational phone calls with Lifestyle Counselor for the first year
- 4 informational DVDs over the two year period
- Feedback on submitted food and exercise journals
ControlBehavioural
- Lifestyle Counselor meetings at baseline, 6 months, and 12 months
- Structured eating plan
- 5 informational NIDDK mailings over the two year period
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months. Maintenance mailings biweekly for six months and then monthly during the second year. Receives: Behavioral: Intervention |
| Control | Placebo comparator | Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Weight & Physical Activity
The primary outcomes of the trial are measured changes in BMI and physical activity level.
Measured: Five years
Secondary outcomes (2)
Cost Effectiveness
Secondary outcomes are cost effectiveness of the intervention as measured by cost per unit of BMI loss. Additional outcomes are changes in stages of change, decision balance, self-efficacy, and problem solving skills during the trial.
Measured: Five Years
Eating Behaviors
Eating behaviors (measured as servings of fruits/vegtables and fat calories consumed) as self reported, Diet History Questionnaire II, SF-12, Eating Behavior Inventory, Three Factor Eating, and General Self Efficacy questionnaires
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles B. Eaton, Memorial Hospital of Rhode Island
- Investigators
- Charles B Eaton, MD, Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542671
- Sponsor's protocol ID
- 09-32
- Other IDs
- 5R18DK079880
- Acronym
- CTL
- Status last verified
- Mar 2016
- First submitted
- 27 Feb 2012
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice
- ClinicalTrials.gov ID
- NCT01542671
- Acronym / sponsor ID
- CTL / 09-32
- Conditions
- Overweight and Obesity
- Keywords
- lifestyle change, obesity treatment, physical activity, primary care, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Mar 2012 (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 primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study. It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort. The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective. The cost of intervention will be evaluated as it relates to study replication.
Detailed description
The study will translate and evaluate previously successful weight loss and physical activity studies into a primary care setting in terms of efficacy and cost effectiveness. Patients are recruited by their primary care physicians office and screened for participation and contraindications by phone. A screening visit with a run-in period of food and exercise log adherence is performed. All participants have meetings with a Lifestyle Counselor to set nutritional and lifestyle goals and an introduction to weight loss techniques at baseline, 6 months, and 12 months. A structured eating plan will be given at the baseline visit. Participants at the baseline visit are randomized to either the intervention and control groups. During the first year, intervention participants will receive monthly motivational phone calls from their lifestyle counselor to assess their progress and help navigate the lifestyle changes. Food and exercise logs are reviewed frequently and written feedback give to each interventional participant. Intervention participants also receive weekly mailings focusing on weight loss, physical activity and healthy eating, and four tailored mailings based upon information gained through contact with the lifestyle counselor. Intervention participants will also receive 2 informative DVDs during the first year. Control participants receive 2 NIDDK informational handouts on weight loss. For the second year of the study focuses on maintenance. Intervention participants receive reduced mailings of 2 per month for 6 months and then once a month until the end of one year. Intervention participants receive one additional motivational phone call at 13 months if they have not reached their weight loss goal and also receive 2 more informative DVDs. The control participants will receive 3 informational NIDDK mailings. The two arms of the study will be compared using the critical outcome measures (weight loss, PA, fat calories \& vegetable/fruit servings consumed) and secondary outcome measures (waist and hip circumference,BP,Heart rate) for weight loss efficacy. We will also evaluate the cost-effectiveness for dissemination as a PCP weight loss program in addition to the overall cost-effectiveness for the participant in terms of money spent and adverse events related to the lifestyle change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionLifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months. Maintenance mailings biweekly for six months and then monthly during the second year. |
| Control | Placebo comparator | Behavioral: ControlLifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/female ≥18 and <80 years old
- Available for this research project for the entire 24-month study period
- Able to read and speak English
- Can provide informed consent
Key exclusion criteria (14 listed)
- Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
- Unstable psychiatric condition
- History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
- Limited physical activity by a physician to less than a brisk walk
- Another family member in the study
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 |
|---|---|---|
| Intervention* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24. * Monthly Motivational phone calls with Lifestyle Counselor for the first year * 4 informational DVDs over the two year period * Feedback on submitted food and exercise journals | Behavioural | Intervention |
| Control* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * 5 informational NIDDK mailings over the two year period | Behavioural | Control |
Primary outcome
Changes in Body Weight & Physical Activity
Time frame: Five years
The primary outcomes of the trial are measured changes in BMI and physical activity level.
2 secondary outcomes
Cost Effectiveness
Time frame: Five Years
Eating Behaviors
Time frame: 5 years
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 4 Apr 2016.
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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.
Charles B Eaton, MD principal investigator
Memorial Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Overweight and Obesity, run by Memorial Hospital of Rhode Island 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 4 inclusion and 14 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 4 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Changes in Body Weight & Physical Activity (time frame: Five years). 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 4 Apr 2016.