Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose (CTL)
|ClinicalTrials.gov Identifier: NCT01542671|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : April 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Intervention Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2015|
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.
Placebo Comparator: Control
Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.
- 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.
- Cost Effectiveness [ Time Frame: Five Years ]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.
- Eating Behaviors [ Time Frame: 5 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542671
|United States, Rhode Island|
|Memorial Hospital of Rhode Island|
|Pawtucket, Rhode Island, United States, 02816`|
|Principal Investigator:||Charles B Eaton, MD||Memorial Hospital of Rhode Island|