Adaptation of the Diabetes Prevention Program for Primary Care
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Adaptation of the Diabetes Prevention Program for Primary Care|
- weight change [ Time Frame: Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72 ]
- change in glucose [ Time Frame: baseline, 6 months & 18 months ]
- change in blood pressure [ Time Frame: baseline, 6 months & 18 months ]
- change in waist circumference [ Time Frame: baseline, 6 months & 18 months ]
- change in lipids [ Time Frame: baseline, 6 months & 18 months ]
- change in health-related quality of life [ Time Frame: baseline & 18 months ]
- cost effectiveness [ Time Frame: 18 months ]
|Study Start Date:||October 2010|
|Study Completion Date:||August 2015|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Standard maintenance
During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance.
Behavioral: Standard maintenance
Participants will receive written materials in months 7-18
Active Comparator: Intensified Maintenance
During months 7 to 18, individuals in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
Behavioral: Intensified maintenance
Participants will continue with in-person counseling visits in months 7-18
This study will be a randomized trial of a weight control intervention, with participants recruited primarily from primary care practices at the University of Colorado. Study treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary research clinic which is part of the University of Colorado School of Medicine. If needed, administrative study visits, such as for informed consent and for completion of questionnaires, may take place at offices in the Division of General Internal Medicine. Up to 200 patients will be enrolled, of which up to 125 will be provided with 6 months of high-intensity weight loss counseling. During the first 6 months, each participant will be seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10, 12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out prior to 6 months. After the first 6 months, the remaining participants will be randomly assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
All participants will use portion-controlled foods to replace 2 meals per day during the first 6 months of treatment and to replace 1 meal per day during months 7 to 18. Participants will purchase their own portion-controlled foods, although in-kind contributions from private industry will be sought to offset participants' food costs. The study consent form will explicitly describe estimated food costs for study participants. The cost of the meal plan, a "partial meal replacement" diet (replacement of 2 out of 3 meals per day) is not expected to increase food costs. Many participants should observe a decrease in food costs while following the meal plan.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220089
|United States, Colorado|
|Center for Human Nutrition|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||Adam G Tsai, MD, MSCE||University of Colorado, Denver|