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

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Carbohydrate Diabetes Prevention Program
Sponsored by
VA Ann Arbor Healthcare System
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 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.

Sites / Locations

  • Department of Veteran Affairs

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

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

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2020
Last Updated
August 5, 2022
Sponsor
VA Ann Arbor Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04881890
Brief Title
Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
Acronym
VA LC-DPP
Official Title
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Ann Arbor Healthcare System

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 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.
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.

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
18 (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
Assess recruitment feasibility and interest in the study
Description
This will be calculated by dividing by number of enrolled participants by the number of individuals invited to participate.
Time Frame
Baseline
Title
Retention of participants in the study
Description
Retention of participants in the study will be determined by the participant completion of surveys
Time Frame
6 months
Title
Retention of participants in the study
Description
Retention of participants in the study will be determined by the participant completion of surveys
Time Frame
12 months
Title
Session attendance
Description
Attendance will determined by the mean number meetings attended by each participant
Time Frame
6 months
Title
Session attendance
Description
Attendance will determined by the mean number meetings attended by each participant
Time Frame
12 months
Title
Acceptability of the program by participants
Description
Determined by semi-structured interview responses
Time Frame
6 month
Title
Acceptability of the program by participants
Description
Determined by semi-structured interview responses
Time Frame
12 month
Title
Adherence with self-weighing
Description
Calculated by dividing the number of self-reported weights by the number of sessions.
Time Frame
6 months
Title
Adherence with self-weighing
Description
Calculated by dividing the number of self-reported weights by the number of sessions.
Time Frame
12 months
Title
Adherence with physical activity goals
Description
Defined by participants that report at least 150 minutes of physical activity in a week.
Time Frame
6 months
Title
Adherence with physical activity goals
Description
Defined by participants that report at least 150 minutes of physical activity in a week.
Time Frame
12 months
Title
Adherence with food tracking
Description
Defined by participants that report maintaining a food log.
Time Frame
6 months
Title
Adherence with food tracking
Description
Defined by participants that report maintaining a food log.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in physical activity measured using the International Physical Activity Questionnaire
Description
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.
Time Frame
6 months to baseline
Title
Change in physical activity measured using the International Physical Activity Questionnaire
Description
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.
Time Frame
12 months to baseline
Title
Change in food cravings measured using the Control of Eating Questionnaire
Description
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.
Time Frame
6 months to baseline
Title
Change in food cravings measured using the Control of Eating Questionnaire
Description
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.
Time Frame
12 months to baseline
Title
Change in stress eating measured using the Palatable Eating Motives Scale
Description
Participants will complete this validated survey.
Time Frame
6 months to baseline
Title
Change in stress eating measured using the Palatable Eating Motives Scale
Description
Participants will complete this validated survey
Time Frame
12 months to baseline
Title
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Description
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 5. The higher value indicated a more positive response.
Time Frame
6 months to baseline
Title
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Description
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 5. The higher value indicated a more positive response.
Time Frame
12 months to baseline
Title
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Description
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 7. The higher value indicated a more positive response.
Time Frame
6 months to baseline
Title
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Description
Participants will complete this validated survey. Minimum Value: 1. Maximum Value: 7. The higher value indicated a more positive response.
Time Frame
12 months to baseline
Title
Measured change in hemoglobin A1c
Description
Measured using a laboratory blood draw
Time Frame
6 months to baseline
Title
Measured change in hemoglobin A1c
Description
Measured using a laboratory blood draw
Time Frame
12 months to baseline
Title
Change in hemoglobin A1c
Description
Baseline A1c will be subtracted from the 6 month A1c.
Time Frame
6 months to baseline
Title
Change in hemoglobin A1c
Description
Baseline A1c will be subtracted from the 12 month A1c.
Time Frame
12 months to baseline
Title
Change in lipid levels
Description
Baseline lipid levels will be subtracted from the 6 month lipid level.
Time Frame
6 months to baseline
Title
Change in lipid levels
Description
Baseline lipid levels will be subtracted from the 12 month lipid level.
Time Frame
12 months to baseline
Title
Percentage of participants who achieve weight loss goal
Description
Determined by the number of participants who lose at least 5% of their body weight during the study
Time Frame
6 month
Title
Percentage of participants who achieve weight loss goal
Description
Determined by the number of participants who lose at least 5% of their body weight during the study
Time Frame
12 month
Title
Change in body weight per participant over the study period
Description
Determined by subtracting the patients baseline weight from their weight at 6 months.
Time Frame
6 months to baseline
Title
Change in body weight per participant over the study period
Description
Determined by subtracting the patients baseline weight from their weight at 12 months.
Time Frame
12 months to baseline
Other Pre-specified Outcome Measures:
Title
Change in physical symptoms
Description
Participants will respond to exploratory survey questions about physical symptoms created by the study team.
Time Frame
6 months to baseline
Title
Change in physical symptoms
Description
Participants will respond to exploratory survey questions about physical symptoms created by the study team.
Time Frame
12 months to baseline

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 1 year 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.
Facility Information:
Facility Name
Department of Veteran Affairs
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes

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