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A Low-Carbohydrate Diabetes Prevention Program

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Carbohydrate Diabetes Prevention Program
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michigan Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low-Carbohydrate Diabetes Prevention Program

Arm Description

At least 20 individuals with prediabetes will participate in a year-long , group-based program.

Outcomes

Primary Outcome Measures

Change in body weight per participant over the study period
Measured as percent body weight loss per participant
Percentage of participants who achieve weight loss goal
Measured as percentange of participants who achieve 5% total body weight loss

Secondary Outcome Measures

Change in self-reported weekly physical activity minutes
Participants will maintain a log of weekly physical activity minutes
Change in physical activity measured using the International Physical Activity Questionnaire
Participants will complete this validated survey
Change in food cravings measured using the Control of Eating Questionnaire
Participants will complete this validated survey
Change in stress eating measured using the Palatable Eating Motives Scale
Participants will complete this validated survey
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Participants will complete this validated survey
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Participants will complete this validated survey
Change in hemoglobin A1c
Measured using a laboratory blood draw
Session attendance
Measured as the number of sessions attended per participant
Study attrition
Number of participants lost to follow-up

Full Information

First Posted
August 15, 2017
Last Updated
December 11, 2018
Sponsor
University of Michigan
Collaborators
National Kidney Foundation of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03258918
Brief Title
A Low-Carbohydrate Diabetes Prevention Program
Official Title
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Individuals With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Kidney Foundation of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Carbohydrate Diabetes Prevention Program
Arm Type
Experimental
Arm Description
At least 20 individuals with prediabetes will participate in a year-long , group-based program.
Intervention Type
Behavioral
Intervention Name(s)
Low-Carbohydrate Diabetes Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight per participant over the study period
Description
Measured as percent body weight loss per participant
Time Frame
Baseline, 12 months
Title
Percentage of participants who achieve weight loss goal
Description
Measured as percentange of participants who achieve 5% total body weight loss
Time Frame
Baseline,12 months
Secondary Outcome Measure Information:
Title
Change in self-reported weekly physical activity minutes
Description
Participants will maintain a log of weekly physical activity minutes
Time Frame
Baseline, 12 months
Title
Change in physical activity measured using the International Physical Activity Questionnaire
Description
Participants will complete this validated survey
Time Frame
Baseline, 12 months
Title
Change in food cravings measured using the Control of Eating Questionnaire
Description
Participants will complete this validated survey
Time Frame
Baseline, 12 months
Title
Change in stress eating measured using the Palatable Eating Motives Scale
Description
Participants will complete this validated survey
Time Frame
Baseline, 12 months
Title
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Description
Participants will complete this validated survey
Time Frame
Baseline, 12 months
Title
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Description
Participants will complete this validated survey
Time Frame
Baseline, 12 months
Title
Change in hemoglobin A1c
Description
Measured using a laboratory blood draw
Time Frame
Baseline, 12 months
Title
Session attendance
Description
Measured as the number of sessions attended per participant
Time Frame
Baseline, 12 months
Title
Study attrition
Description
Number of participants lost to follow-up
Time Frame
Baseline, 12 months
Other Pre-specified Outcome Measures:
Title
Change in diet as assessed by qualitative review of foods logs
Description
Participants will maintain weekly food logs
Time Frame
Baseline, 12 months
Title
Change in diet as assessed by response to survey questions
Description
Participants will respond to exploratory survey questions about diet created by the study team.
Time Frame
Baseline, 12 months
Title
Change in physical symptoms
Description
Participants will respond to exploratory survey questions about physical symptoms created by the study team.
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Overweight, defined as BMI≥25 kg/m2 [31] HbA1c between 5.7-6.4% drawn within 6 months of the study start date Willingness to participate in group-based classes Able to engage in at least light physical activities such as walking. Exclusion criteria: History of type 1 diabetes or type 2 diabetes Current participation in another lifestyle or behavior change program or research study Vegetarian or vegan lifestyle History of bariatric surgery Inability to read, write, or speak English Inability to provide informed consent Women who are pregnant or intend to become pregnant during the intervention period. 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.
Facility Information:
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31969366
Citation
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.
Results Reference
derived

Learn more about this trial

A Low-Carbohydrate Diabetes Prevention Program

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