Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/14/2017 |
| Start Date: | September 2009 |
| End Date: | July 2015 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
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Memorial Hospital of Rhode Island Memorial Hospital of Rhode Island is a 294-bed community teaching...
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