- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04881890
Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes (VA LC-DPP)
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48104
- Department of Veteran Affairs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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.
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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
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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.
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Baseline
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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
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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
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Attendance will determined by the mean number meetings attended by each participant
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12 months
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Acceptability of the program by participants
Time Frame: 6 month
|
Determined by semi-structured interview responses
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6 month
|
Acceptability of the program by participants
Time Frame: 12 month
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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.
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6 months
|
Adherence with self-weighing
Time Frame: 12 months
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Calculated by dividing the number of self-reported weights by the number of sessions.
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12 months
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Adherence with physical activity goals
Time Frame: 6 months
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Defined by participants that report at least 150 minutes of physical activity in a week.
|
6 months
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Adherence with physical activity goals
Time Frame: 12 months
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Defined by participants that report at least 150 minutes of physical activity in a week.
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12 months
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Adherence with food tracking
Time Frame: 6 months
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Defined by participants that report maintaining a food log.
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6 months
|
Adherence with food tracking
Time Frame: 12 months
|
Defined by participants that report maintaining a food log.
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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.
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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.
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12 months to baseline
|
Change in food cravings measured using the Control of Eating Questionnaire
Time Frame: 6 months to baseline
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Participants will complete this validated survey.
Minimum value: 0, Maximum Value: 100.
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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.
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12 months to baseline
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Change in stress eating measured using the Palatable Eating Motives Scale
Time Frame: 6 months to baseline
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Participants will complete this validated survey.
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6 months to baseline
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Change in stress eating measured using the Palatable Eating Motives Scale
Time Frame: 12 months to baseline
|
Participants will complete this validated survey
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12 months to baseline
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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.
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6 months to baseline
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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.
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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
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Measured using a laboratory blood draw
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6 months to baseline
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Measured change in hemoglobin A1c
Time Frame: 12 months to baseline
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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.
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6 months to baseline
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Change in hemoglobin A1c
Time Frame: 12 months to baseline
|
Baseline A1c will be subtracted from the 12 month A1c.
|
12 months to baseline
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Change in lipid levels
Time Frame: 6 months to baseline
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Baseline lipid levels will be subtracted from the 6 month lipid level.
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6 months to baseline
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Change in lipid levels
Time Frame: 12 months to baseline
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Baseline lipid levels will be subtracted from the 12 month lipid level.
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12 months to baseline
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Percentage of participants who achieve weight loss goal
Time Frame: 6 month
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Determined by the number of participants who lose at least 5% of their body weight during the study
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6 month
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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
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Change in body weight per participant over the study period
Time Frame: 6 months to baseline
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Determined by subtracting the patients baseline weight from their weight at 6 months.
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6 months to baseline
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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
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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.
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6 months to baseline
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIP 20-122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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