Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes (VA LC-DPP)

August 5, 2022 updated by: VA Ann Arbor Healthcare System

A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes

The investigators will conduct a single-arm mixed methods pilot study to examine the feasibility and acceptability of a low-carbohydrate diabetes prevention program (LC-DPP). The investigators will estimate weight loss as well as the percentage of participants who achieve 5% body weight loss at 6 month and 12 month timepoints. Weight loss from the pilot VA LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies and the VA MOVE! program. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 12-month study period. The investigators will also conduct qualitative interviews with participants at 6 and 12 months.

Study Overview

Status

Completed

Conditions

Detailed Description

The Veteran population faces high rates of T2DM with estimates surpassing 20% compared to 14% among the general population. Furthermore, an estimated 25% of overweight or obese Veterans have prediabetes and many will progress to T2DM over time. Fortunately, T2DM can be prevented or delayed through dietary and physical activity changes that promote weight loss of ≥5% body weight. To help Veterans lose weight and avoid obesity-related chronic conditions such as T2DM, the VA Health System offers a lifestyle change program, VA MOVE!. Although MOVE! is widely adopted across the VA Health System, weight loss outcomes are modest (range of 0.13-3.3 kg loss over one year) and less than 20% of participants achieve ≥5% weight loss.

Novel strategies are needed to help more Veterans to lose weight and prevent and manage obesity-related conditions. One promising approach may be through a low-carbohydrate dietary intervention. Consistent with historic United States Dietary Guidelines, diabetes prevention clinical trials and their translational group-based programs, including VA MOVE!, recommend a low-fat, calorie-restricted diet. However, the scientific merit of this recommendation has been criticized. Growing evidence supports the efficacy of low-carbohydrate diets (defined <26% total energy from carbohydrate per day) and VLCDs (defined as <10% of total energy from carbohydrate per day) for short-term weight loss, long-term weight maintenance, and improved glycemic control, particularly among individuals with T2DM and insulin resistance.

The objectives of this single-arm mixed methods pilot study are (1) to test the feasibility and acceptability of a low-carbohydrate Diabetes Prevention Program (LC-DPP) among Veterans with prediabetes and (2) to estimate weight loss among LC-DPP participants.

The investigators will recruit approximately 22 patients with body mass index ≥ 25 kg/m2 and prediabetes (defined as hemoglobin A1c [A1c] 5.7-6.4%). Participants will be identified by chart review and invited to participate by postal letter. Individuals that do not opt-out of study contact will be screened for eligibility by telephone call. Interested and eligible participants will be invited to attend an in-person information session. During this session, they will receive information about the dietary intervention; written informed consent will be obtained at this time. Study participants will attend a total of 24 group-based classes over the course of 1-year. Body weight will be measured at each session. At 0, 6, and 12-months, the investigators will measure hemoglobin A1c (HbA1c) and cholesterol levels as well as self-reported measures of quality of life, mood, hunger, cravings, and physical symptoms. Primary outcomes will be feasibility (e.g., enrollment, retention) and acceptability (e.g., session attendance, qualitative feedback). Secondary outcomes will change in weight, achievement of ≥5% body weight loss, change in HbA1c, and change in cholesterol levels. During semi-structured interviewed conducted at 6-months and 12-months, the investigators will explore participants' experiences with the program, barriers to and facilitators of adherence to a low-carbohydrate diet, and perspectives on ways to improve the intervention.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Department of Veteran Affairs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Overweight, defined as BMI≥25 kg/m2 [31]
  2. HbA1c between 5.7-6.4% drawn within 1 year 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-Carbohydrate Diabetes Prevention Program
At least 20 individuals with prediabetes will participate in a year-long , group-based 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess recruitment feasibility and interest in the study
Time Frame: Baseline
This will be calculated by dividing by number of enrolled participants by the number of individuals invited to participate.
Baseline
Retention of participants in the study
Time Frame: 6 months
Retention of participants in the study will be determined by the participant completion of surveys
6 months
Retention of participants in the study
Time Frame: 12 months
Retention of participants in the study will be determined by the participant completion of surveys
12 months
Session attendance
Time Frame: 6 months
Attendance will determined by the mean number meetings attended by each participant
6 months
Session attendance
Time Frame: 12 months
Attendance will determined by the mean number meetings attended by each participant
12 months
Acceptability of the program by participants
Time Frame: 6 month
Determined by semi-structured interview responses
6 month
Acceptability of the program by participants
Time Frame: 12 month
Determined by semi-structured interview responses
12 month
Adherence with self-weighing
Time Frame: 6 months
Calculated by dividing the number of self-reported weights by the number of sessions.
6 months
Adherence with self-weighing
Time Frame: 12 months
Calculated by dividing the number of self-reported weights by the number of sessions.
12 months
Adherence with physical activity goals
Time Frame: 6 months
Defined by participants that report at least 150 minutes of physical activity in a week.
6 months
Adherence with physical activity goals
Time Frame: 12 months
Defined by participants that report at least 150 minutes of physical activity in a week.
12 months
Adherence with food tracking
Time Frame: 6 months
Defined by participants that report maintaining a food log.
6 months
Adherence with food tracking
Time Frame: 12 months
Defined by participants that report maintaining a food log.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical activity measured using the International Physical Activity Questionnaire
Time Frame: 6 months to baseline
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.
6 months to baseline
Change in physical activity measured using the International Physical Activity Questionnaire
Time Frame: 12 months to baseline
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.
12 months to baseline
Change in food cravings measured using the Control of Eating Questionnaire
Time Frame: 6 months to baseline
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.
6 months to baseline
Change in food cravings measured using the Control of Eating Questionnaire
Time Frame: 12 months to baseline
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.
12 months to baseline
Change in stress eating measured using the Palatable Eating Motives Scale
Time Frame: 6 months to baseline
Participants will complete this validated survey.
6 months to baseline
Change in stress eating measured using the Palatable Eating Motives Scale
Time Frame: 12 months to baseline
Participants will complete this validated survey
12 months to baseline
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Time Frame: 6 months to baseline
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 5. The higher value indicated a more positive response.
6 months to baseline
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Time Frame: 12 months to baseline
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 5. The higher value indicated a more positive response.
12 months to baseline
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Time Frame: 6 months to baseline
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 7. The higher value indicated a more positive response.
6 months to baseline
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Time Frame: 12 months to baseline
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 7. The higher value indicated a more positive response.
12 months to baseline
Measured change in hemoglobin A1c
Time Frame: 6 months to baseline
Measured using a laboratory blood draw
6 months to baseline
Measured change in hemoglobin A1c
Time Frame: 12 months to baseline
Measured using a laboratory blood draw
12 months to baseline
Change in hemoglobin A1c
Time Frame: 6 months to baseline
Baseline A1c will be subtracted from the 6 month A1c.
6 months to baseline
Change in hemoglobin A1c
Time Frame: 12 months to baseline
Baseline A1c will be subtracted from the 12 month A1c.
12 months to baseline
Change in lipid levels
Time Frame: 6 months to baseline
Baseline lipid levels will be subtracted from the 6 month lipid level.
6 months to baseline
Change in lipid levels
Time Frame: 12 months to baseline
Baseline lipid levels will be subtracted from the 12 month lipid level.
12 months to baseline
Percentage of participants who achieve weight loss goal
Time Frame: 6 month
Determined by the number of participants who lose at least 5% of their body weight during the study
6 month
Percentage of participants who achieve weight loss goal
Time Frame: 12 month
Determined by the number of participants who lose at least 5% of their body weight during the study
12 month
Change in body weight per participant over the study period
Time Frame: 6 months to baseline
Determined by subtracting the patients baseline weight from their weight at 6 months.
6 months to baseline
Change in body weight per participant over the study period
Time Frame: 12 months to baseline
Determined by subtracting the patients baseline weight from their weight at 12 months.
12 months to baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical symptoms
Time Frame: 6 months to baseline
Participants will respond to exploratory survey questions about physical symptoms created by the study team.
6 months to baseline
Change in physical symptoms
Time Frame: 12 months to baseline
Participants will respond to exploratory survey questions about physical symptoms created by the study team.
12 months to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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