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A Low-Carbohydrate Diabetes Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258918
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
National Kidney Foundation of Michigan
Information provided by (Responsible Party):
Dina Griauzde, Internal Medicine, University of Michigan

Tracking Information
First Submitted Date  ICMJE August 15, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE September 11, 2017
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Change in body weight per participant over the study period [ Time Frame: Baseline, 12 months ]
    Measured as percent body weight loss per participant
  • Percentage of participants who achieve weight loss goal [ Time Frame: Baseline,12 months ]
    Measured as percentange of participants who achieve 5% total body weight loss
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Change in self-reported weekly physical activity minutes [ Time Frame: Baseline, 12 months ]
    Participants will maintain a log of weekly physical activity minutes
  • Change in physical activity measured using the International Physical Activity Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey
  • Change in food cravings measured using the Control of Eating Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey
  • Change in stress eating measured using the Palatable Eating Motives Scale [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey
  • Change in self-reported health measured using the Global Health PROMIS Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey
  • Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey
  • Change in hemoglobin A1c [ Time Frame: Baseline, 12 months ]
    Measured using a laboratory blood draw
  • Session attendance [ Time Frame: Baseline, 12 months ]
    Measured as the number of sessions attended per participant
  • Study attrition [ Time Frame: Baseline, 12 months ]
    Number of participants lost to follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 22, 2017)
  • Change in diet as assessed by qualitative review of foods logs [ Time Frame: Baseline, 12 months ]
    Participants will maintain weekly food logs
  • Change in diet as assessed by response to survey questions [ Time Frame: Baseline, 12 months ]
    Participants will respond to exploratory survey questions about diet created by the study team.
  • Change in physical symptoms [ Time Frame: Baseline, 12 months ]
    Participants will respond to exploratory survey questions about physical symptoms created by the study team.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Low-Carbohydrate Diabetes Prevention Program
Official Title  ICMJE A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Individuals With Prediabetes
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE PreDiabetes
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Low-Carbohydrate Diabetes Prevention Program
At least 20 individuals with prediabetes will participate in a year-long , group-based program.
Intervention: Behavioral: Low-Carbohydrate Diabetes Prevention Program
Publications * Hafez Griauzde D, Saslow L, Patterson K, Ansari T, Liestenfeltz B, Tisack A, Bihn P, Shopinski S, Richardson CR. Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA. BMJ Open. 2020 Jan 21;10(1):e033397. doi: 10.1136/bmjopen-2019-033397.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2017)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 7, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Overweight, defined as BMI≥25 kg/m2 [31]
  2. HbA1c between 5.7-6.4% drawn within 6 months of the study start date
  3. Willingness to participate in group-based classes
  4. Able to engage in at least light physical activities such as walking.

Exclusion criteria:

  1. History of type 1 diabetes or type 2 diabetes
  2. Current participation in another lifestyle or behavior change program or research study
  3. Vegetarian or vegan lifestyle
  4. History of bariatric surgery
  5. Inability to read, write, or speak English
  6. Inability to provide informed consent
  7. Women who are pregnant or intend to become pregnant during the intervention period.
  8. Insured by Premier Care or Grad Care; these individuals have the opportunity to participate in a standard DPP, which is offered as a covered benefit through their health plan.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03258918
Other Study ID Numbers  ICMJE F046400
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dina Griauzde, Internal Medicine, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Kidney Foundation of Michigan
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP