An interventional study of Intervention and Control in Overweight and Obesity, sponsored by Memorial Hospital of Rhode Island. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-04.
Sponsored by Memorial Hospital of Rhode Island · Not applicable, Interventional, and Treatment
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 200 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Memorial Hospital of Rhode Island is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Intervention
Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.
Behavioral: Control
* 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
* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * 5 informational NIDDK mailings over the two year period
Changes in Body Weight & Physical Activity
The primary outcomes of the trial are measured changes in BMI and physical activity level.
Time frame: Five years
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.
Time frame: 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
Time frame: 5 years
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Memorial Hospital of Rhode Island