An interventional study of Low-Carbohydrate Diabetes Prevention Program in PreDiabetes, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss as well as the percentage of participants who achieve 5% weight loss in a 16-week, Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.
An estimated 86 million US adults are have prediabetes, and, without intervention, many will develop T2DM over time. Fortunately, T2DM can be prevented or delayed through modest lifestyle changes. The landmark Diabetes Prevention Program (DPP) Trial demonstrated a 58 percent reduction in the 3-year incidence of T2DM among individuals with prediabetes who achieved 7 percent body weight loss and engaged in routine physical activity. Accordingly, the DPP lifestyle intervention has been translated to communities across the United States, and, on average, participant weight change is 4 percent at 12 months. Thus, while group-based DPPs and can effectively promote weight loss among some participants, many DPP participants do not achieve the program goal of 5 to 7 percent body weight loss.
Novel strategies to help participants achieve DPP weight-loss goals are important for two key reasons. First, weight loss is the primary driver of T2DM risk reduction, and the potential population health impact of the intervention is diminished when participants do not lose weight. Second, a growing number of health plans including Medicare offer coverage for the DPP and proposed reimbursement is largely tied to weight loss of at least 5 percent at 6 months and 12 months. The DPP costs approximately $400-$500 per participant per year. Unfortunately, organizations that offer the DPP may be reimbursed for much less than this if participants do not meet weight loss goals, which could significantly compromise the program's long-term financial sustainability.
One promising approach to help DPP participants lose more weight may be through a low-carbohydrate (LC) dietary intervention. Consistent with United States Dietary Guidelines (USDG), the original DPP Trial and translational group-based curricula recommend a low-fat (LF), calorie-restricted diet. However, there is growing controversy regarding the scientific merit of the Dietary Guidelines as well as growing recognition that LC diets may be more effective than LF diets for short-term weight loss and long-term weight maintenance. Notably, weight loss occurs without calorie restriction and LC diets improve blood glucose levels among individuals with T2DM and insulin resistance. Thus, a LC dietary intervention for prediabetes may augment individual weight loss and T2DM risk reduction while also maximizing third-party reimbursement.
The aim of this mixed methods pilot study is to test whether a LC-DPP may lead to greater weight loss than the original DPP. In addition to objective measures of this program's preliminary efficacy (e.g. weight, HbA1c) the study team will also obtain qualitative participant feedback on the intervention. Taken together, these data will be used to improve the curriculum and inform a larger-scale intervention.
Exclusion criteria:
At least 20 individuals with prediabetes will participate in a year-long , group-based program.
Behavioral: Low-Carbohydrate Diabetes Prevention Program
LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.
Change in body weight per participant over the study period
Measured as percent body weight loss per participant
Time frame: Baseline, 12 months
Percentage of participants who achieve weight loss goal
Measured as percentange of participants who achieve 5% total body weight loss
Time frame: Baseline,12 months
Change in self-reported weekly physical activity minutes
Participants will maintain a log of weekly physical activity minutes
Time frame: Baseline, 12 months
Change in physical activity measured using the International Physical Activity Questionnaire
Participants will complete this validated survey
Time frame: Baseline, 12 months
Change in food cravings measured using the Control of Eating Questionnaire
Participants will complete this validated survey
Time frame: Baseline, 12 months
Change in stress eating measured using the Palatable Eating Motives Scale
Participants will complete this validated survey
Time frame: Baseline, 12 months
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Participants will complete this validated survey
Time frame: Baseline, 12 months
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Participants will complete this validated survey
Time frame: Baseline, 12 months
Change in hemoglobin A1c
Measured using a laboratory blood draw
Time frame: Baseline, 12 months
Session attendance
Measured as the number of sessions attended per participant
Time frame: Baseline, 12 months
Study attrition
Number of participants lost to follow-up
Time frame: Baseline, 12 months
Change in diet as assessed by qualitative review of foods logs
Participants will maintain weekly food logs
Time frame: Baseline, 12 months
Change in diet as assessed by response to survey questions
Participants will respond to exploratory survey questions about diet created by the study team.
Time frame: Baseline, 12 months
Change in physical symptoms
Participants will respond to exploratory survey questions about physical symptoms created by the study team.
Time frame: Baseline, 12 months
Plan to share: No
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Michigan