NCT03258918

Brief Summary

The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss as well as the percentage of participants who achieve 5% weight loss in a 16-week, Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

August 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

August 15, 2017

Last Update Submit

December 11, 2018

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (2)

  • Change in body weight per participant over the study period

    Measured as percent body weight loss per participant

    Baseline, 12 months

  • Percentage of participants who achieve weight loss goal

    Measured as percentange of participants who achieve 5% total body weight loss

    Baseline,12 months

Secondary Outcomes (9)

  • Change in self-reported weekly physical activity minutes

    Baseline, 12 months

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

    Baseline, 12 months

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

    Baseline, 12 months

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

    Baseline, 12 months

  • Change in self-reported health measured using the Global Health PROMIS Questionnaire

    Baseline, 12 months

  • +4 more secondary outcomes

Other Outcomes (3)

  • Change in diet as assessed by qualitative review of foods logs

    Baseline, 12 months

  • Change in diet as assessed by response to survey questions

    Baseline, 12 months

  • Change in physical symptoms

    Baseline, 12 months

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 6 months 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.
  • Insured by Premier Care or Grad Care; these individuals have the opportunity to participate in a standard DPP, which is offered as a covered benefit through their health plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Hafez Griauzde D, Saslow L, Patterson K, Ansari T, Liestenfeltz B, Tisack A, Bihn P, Shopinski S, Richardson CR. Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA. BMJ Open. 2020 Jan 21;10(1):e033397. doi: 10.1136/bmjopen-2019-033397.

    PMID: 31969366DERIVED

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 23, 2017

Study Start

September 11, 2017

Primary Completion

November 7, 2018

Study Completion

November 7, 2018

Last Updated

December 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)