NCT04881890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

November 17, 2020

Last Update Submit

August 5, 2022

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (13)

  • 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

  • Retention of participants in the study

    Retention of participants in the study will be determined by the participant completion of surveys

    6 months

  • Retention of participants in the study

    Retention of participants in the study will be determined by the participant completion of surveys

    12 months

  • Session attendance

    Attendance will determined by the mean number meetings attended by each participant

    6 months

  • Session attendance

    Attendance will determined by the mean number meetings attended by each participant

    12 months

  • Acceptability of the program by participants

    Determined by semi-structured interview responses

    6 month

  • Acceptability of the program by participants

    Determined by semi-structured interview responses

    12 month

  • Adherence with self-weighing

    Calculated by dividing the number of self-reported weights by the number of sessions.

    6 months

  • Adherence with self-weighing

    Calculated by dividing the number of self-reported weights by the number of sessions.

    12 months

  • Adherence with physical activity goals

    Defined by participants that report at least 150 minutes of physical activity in a week.

    6 months

  • Adherence with physical activity goals

    Defined by participants that report at least 150 minutes of physical activity in a week.

    12 months

  • Adherence with food tracking

    Defined by participants that report maintaining a food log.

    6 months

  • Adherence with food tracking

    Defined by participants that report maintaining a food log.

    12 months

Secondary Outcomes (20)

  • Change in physical activity measured using the International Physical Activity Questionnaire

    6 months to baseline

  • Change in physical activity measured using the International Physical Activity Questionnaire

    12 months to baseline

  • Change in food cravings measured using the Control of Eating Questionnaire

    6 months to baseline

  • Change in food cravings measured using the Control of Eating Questionnaire

    12 months to baseline

  • Change in stress eating measured using the Palatable Eating Motives Scale

    6 months to baseline

  • +15 more secondary outcomes

Other Outcomes (2)

  • Change in physical symptoms

    6 months to baseline

  • Change in physical symptoms

    12 months to baseline

Study Arms (1)

Low-Carbohydrate Diabetes Prevention Program

EXPERIMENTAL

At least 20 individuals with prediabetes will participate in a year-long , group-based program.

Behavioral: Low-Carbohydrate Diabetes Prevention Program

Interventions

Low-Carbohydrate Diabetes Prevention ProgramBEHAVIORAL

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

Low-Carbohydrate Diabetes Prevention Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Veteran Affairs

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (1)

  • 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.

    PMID: 37266128DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

May 11, 2021

Study Start

October 5, 2020

Primary Completion

September 30, 2021

Study Completion

December 22, 2021

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)