Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes

PreDiabetes Clinical Trial

— VA LC-DPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881890
• Other study ID #: LIP 20-122
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: December 22, 2021

Study information

• Verified date: August 2022
• Source: VA Ann Arbor Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 22, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Department of Veteran Affairs	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Ann Arbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical symptoms	Participants will respond to exploratory survey questions about physical symptoms created by the study team.	6 months to baseline
Other	Change in physical symptoms	Participants will respond to exploratory survey questions about physical symptoms created by the study team.	12 months to baseline
Primary	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.	Baseline
Primary	Retention of participants in the study	Retention of participants in the study will be determined by the participant completion of surveys	6 months
Primary	Retention of participants in the study	Retention of participants in the study will be determined by the participant completion of surveys	12 months
Primary	Session attendance	Attendance will determined by the mean number meetings attended by each participant	6 months
Primary	Session attendance	Attendance will determined by the mean number meetings attended by each participant	12 months
Primary	Acceptability of the program by participants	Determined by semi-structured interview responses	6 month
Primary	Acceptability of the program by participants	Determined by semi-structured interview responses	12 month
Primary	Adherence with self-weighing	Calculated by dividing the number of self-reported weights by the number of sessions.	6 months
Primary	Adherence with self-weighing	Calculated by dividing the number of self-reported weights by the number of sessions.	12 months
Primary	Adherence with physical activity goals	Defined by participants that report at least 150 minutes of physical activity in a week.	6 months
Primary	Adherence with physical activity goals	Defined by participants that report at least 150 minutes of physical activity in a week.	12 months
Primary	Adherence with food tracking	Defined by participants that report maintaining a food log.	6 months
Primary	Adherence with food tracking	Defined by participants that report maintaining a food log.	12 months
Secondary	Change in physical activity measured using the International Physical Activity Questionnaire	Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.	6 months to baseline
Secondary	Change in physical activity measured using the International Physical Activity Questionnaire	Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.	12 months to baseline
Secondary	Change in food cravings measured using the Control of Eating Questionnaire	Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.	6 months to baseline
Secondary	Change in food cravings measured using the Control of Eating Questionnaire	Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.	12 months to baseline
Secondary	Change in stress eating measured using the Palatable Eating Motives Scale	Participants will complete this validated survey.	6 months to baseline
Secondary	Change in stress eating measured using the Palatable Eating Motives Scale	Participants will complete this validated survey	12 months to baseline
Secondary	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.	6 months to baseline
Secondary	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.	12 months to baseline
Secondary	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.	6 months to baseline
Secondary	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.	12 months to baseline
Secondary	Measured change in hemoglobin A1c	Measured using a laboratory blood draw	6 months to baseline
Secondary	Measured change in hemoglobin A1c	Measured using a laboratory blood draw	12 months to baseline
Secondary	Change in hemoglobin A1c	Baseline A1c will be subtracted from the 6 month A1c.	6 months to baseline
Secondary	Change in hemoglobin A1c	Baseline A1c will be subtracted from the 12 month A1c.	12 months to baseline
Secondary	Change in lipid levels	Baseline lipid levels will be subtracted from the 6 month lipid level.	6 months to baseline
Secondary	Change in lipid levels	Baseline lipid levels will be subtracted from the 12 month lipid level.	12 months to baseline
Secondary	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	6 month
Secondary	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	12 month
Secondary	Change in body weight per participant over the study period	Determined by subtracting the patients baseline weight from their weight at 6 months.	6 months to baseline
Secondary	Change in body weight per participant over the study period	Determined by subtracting the patients baseline weight from their weight at 12 months.	12 months to baseline