PreDiabetesVA LC-DPPNCT04881890
Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
A study testing Low-Carbohydrate Diabetes Prevention Program in people with PreDiabetes, run by VA Ann Arbor Healthcare System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Low-Carbohydrate Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 22 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veteran Affairs
Ann Arbor, Michigan, 48104
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Low-Carbohydrate Diabetes Prevention Program
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Carbohydrate Diabetes Prevention ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Low-Carbohydrate Diabetes Prevention Program | Experimental | At least 20 individuals with prediabetes will participate in a year-long , group-based program. Receives: Behavioral: Low-Carbohydrate Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Retention of participants in the study
Retention of participants in the study will be determined by the participant completion of surveys
Measured: 6 months
Retention of participants in the study
Retention of participants in the study will be determined by the participant completion of surveys
Measured: 12 months
Session attendance
Attendance will determined by the mean number meetings attended by each participant
Measured: 6 months
Session attendance
Attendance will determined by the mean number meetings attended by each participant
Measured: 12 months
Acceptability of the program by participants
Determined by semi-structured interview responses
Measured: 6 month
Acceptability of the program by participants
Determined by semi-structured interview responses
Measured: 12 month
Adherence with self-weighing
Calculated by dividing the number of self-reported weights by the number of sessions.
Measured: 6 months
Adherence with self-weighing
Calculated by dividing the number of self-reported weights by the number of sessions.
Measured: 12 months
Adherence with physical activity goals
Defined by participants that report at least 150 minutes of physical activity in a week.
Measured: 6 months
Adherence with physical activity goals
Defined by participants that report at least 150 minutes of physical activity in a week.
Measured: 12 months
Adherence with food tracking
Defined by participants that report maintaining a food log.
Measured: 6 months
Adherence with food tracking
Defined by participants that report maintaining a food log.
Measured: 12 months
Secondary outcomes (20)
Change in physical activity measured using the International Physical Activity Questionnaire
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.
Measured: 6 months to baseline
Change in physical activity measured using the International Physical Activity Questionnaire
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 9.
Measured: 12 months to baseline
Change in food cravings measured using the Control of Eating Questionnaire
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.
Measured: 6 months to baseline
Change in food cravings measured using the Control of Eating Questionnaire
Participants will complete this validated survey. Minimum value: 0, Maximum Value: 100.
Measured: 12 months to baseline
Change in stress eating measured using the Palatable Eating Motives Scale
Participants will complete this validated survey.
Measured: 6 months to baseline
Change in stress eating measured using the Palatable Eating Motives Scale
Participants will complete this validated survey
Measured: 12 months to baseline
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.
Measured: 6 months to baseline
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.
Measured: 12 months to baseline
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: 6 months to baseline
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: 12 months to baseline
Measured change in hemoglobin A1c
Measured using a laboratory blood draw
Measured: 6 months to baseline
Measured change in hemoglobin A1c
Measured using a laboratory blood draw
Measured: 12 months to baseline
Change in hemoglobin A1c
Baseline A1c will be subtracted from the 6 month A1c.
Measured: 6 months to baseline
Change in hemoglobin A1c
Baseline A1c will be subtracted from the 12 month A1c.
Measured: 12 months to baseline
Change in lipid levels
Baseline lipid levels will be subtracted from the 6 month lipid level.
Measured: 6 months to baseline
Change in lipid levels
Baseline lipid levels will be subtracted from the 12 month lipid level.
Measured: 12 months to baseline
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
Measured: 6 month
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
Measured: 12 month
Change in body weight per participant over the study period
Determined by subtracting the patients baseline weight from their weight at 6 months.
Measured: 6 months to baseline
Change in body weight per participant over the study period
Determined by subtracting the patients baseline weight from their weight at 12 months.
Measured: 12 months to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start5 Oct 2020
- Primary completion30 Sep 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Ann Arbor Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881890
- Sponsor's protocol ID
- LIP 20-122
- Acronym
- VA LC-DPP
- Status last verified
- Aug 2022
- First submitted
- 17 Nov 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griauzde DH, Hershey C, Michaels J, Evans RR, Richardson CR, Heisler M, Kullgren JT, Saslow LR. A very low-carbohydrate diabetes prevention program for veterans with prediabetes: a single-arm mixed methods pilot study. Front Nutr. 2023 May 17;10:1069266. doi: 10.3389/fnut.2023.1069266. eCollection 2023.
PubMed 37266128
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
- ClinicalTrials.gov ID
- NCT04881890
- Acronym / sponsor ID
- VA LC-DPP / LIP 20-122
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- VA Ann Arbor Healthcare SystemUS federal agency
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Carbohydrate Diabetes Prevention Program | Experimental | Behavioral: Low-Carbohydrate Diabetes Prevention ProgramAt least 20 individuals with prediabetes will participate in a year-long , group-based program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Carbohydrate Diabetes Prevention ProgramLC-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 | Behavioural | Low-Carbohydrate Diabetes Prevention Program |
Primary outcome
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.
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
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
Session attendance
Time frame: 6 months
Attendance will determined by the mean number meetings attended by each participant
Session attendance
Time frame: 12 months
Attendance will determined by the mean number meetings attended by each participant
Acceptability of the program by participants
Time frame: 6 month
Determined by semi-structured interview responses
Acceptability of the program by participants
Time frame: 12 month
Determined by semi-structured interview responses
Adherence with self-weighing
Time frame: 6 months
Calculated by dividing the number of self-reported weights by the number of sessions.
Adherence with self-weighing
Time frame: 12 months
Calculated by dividing the number of self-reported weights by the number of sessions.
Adherence with physical activity goals
Time frame: 6 months
Defined by participants that report at least 150 minutes of physical activity in a week.
Adherence with physical activity goals
Time frame: 12 months
Defined by participants that report at least 150 minutes of physical activity in a week.
Adherence with food tracking
Time frame: 6 months
Defined by participants that report maintaining a food log.
Adherence with food tracking
Time frame: 12 months
Defined by participants that report maintaining a food log.
20 secondary outcomes
Change in physical activity measured using the International Physical Activity Questionnaire
Time frame: 6 months to baseline
Change in physical activity measured using the International Physical Activity Questionnaire
Time frame: 12 months to baseline
Change in food cravings measured using the Control of Eating Questionnaire
Time frame: 6 months to baseline
Change in food cravings measured using the Control of Eating Questionnaire
Time frame: 12 months to baseline
Change in stress eating measured using the Palatable Eating Motives Scale
Time frame: 6 months to baseline
Change in stress eating measured using the Palatable Eating Motives Scale
Time frame: 12 months to baseline
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Time frame: 6 months to baseline
Change in self-reported health measured using the Global Health PROMIS Questionnaire
Time frame: 12 months to baseline
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Time frame: 6 months to baseline
Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
Time frame: 12 months to baseline
Measured change in hemoglobin A1c
Time frame: 6 months to baseline
Measured change in hemoglobin A1c
Time frame: 12 months to baseline
Change in hemoglobin A1c
Time frame: 6 months to baseline
Change in hemoglobin A1c
Time frame: 12 months to baseline
Change in lipid levels
Time frame: 6 months to baseline
Change in lipid levels
Time frame: 12 months to baseline
Percentage of participants who achieve weight loss goal
Time frame: 6 month
Percentage of participants who achieve weight loss goal
Time frame: 12 month
Change in body weight per participant over the study period
Time frame: 6 months to baseline
Change in body weight per participant over the study period
Time frame: 12 months to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 37266128Griauzde DH, Hershey C, Michaels J, Evans RR, Richardson CR, Heisler M, Kullgren JT, Saslow LR. A very low-carbohydrate diabetes prevention program for veterans with prediabetes: a single-arm mixed methods pilot study. Front Nutr. 2023 May 17;10:1069266. doi: 10.3389/fnut.2023.1069266. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Carbohydrate Diabetes Prevention Program in people with PreDiabetes, run by VA Ann Arbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess recruitment feasibility and interest in the study (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.