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ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development) (ACT1ON DP3)

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ClinicalTrials.gov Identifier: NCT03651622
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 27, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date January 9, 2019
Actual Study Start Date  ICMJE November 12, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Change in weight - Randomization 1 [ Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit ]
    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
  • Change in weight - Randomization 2 [ Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit ]
    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
  • Change in weight - Randomization 3 [ Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit ]
    Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
  • Change in HbA1C - Randomization 1 [ Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit ]
    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
  • Change in HbA1C - Randomization 2 [ Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit ]
    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
  • Change in HbA1C - Randomization 3 [ Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit ]
    HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
  • Difference in Percent Time Spent in Hypoglycemia - Randomization 1 [ Time Frame: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit ]
    Change in the percent of time spent in hypoglycemia during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.
  • Difference in Percent Time Spent in Hypoglycemia - Randomization 2 [ Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit ]
    Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
  • Difference in Percent Time Spent in Hypoglycemia - Randomization 3 [ Time Frame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit ]
    Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03651622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Change in percent body fat - Randomization 1 [ Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit ]
    Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.
  • Change in percent body fat - Randomization 2 [ Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit ]
    Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period.
  • Change in percent body fat - Randomization 3 [ Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit ]
    Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period.
  • Difference in time spent within target blood glucose range - Randomization 1 [ Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit ]
    Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.
  • Difference in time spent within target blood glucose range - Randomization 2 [ Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit ]
    Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
  • Difference in time spent within target blood glucose range - Randomization 3 [ Time Frame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit ]
    Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
Official Title  ICMJE Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes
Brief Summary An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.
Detailed Description

Eighty-four participants will be randomized in total; 42 recruited at the University of North Carolina (UNC), 42 recruited at Stanford.

Procedures (methods):

Three distinct dietary approaches will be tested. Dietary approaches are as follows:

Diet 1: hypocaloric, moderate low fat (30% calories from fat) weight management based on the Look AHEAD study Diet 2: hypocaloric, low carbohydrate (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat) Diet 3: advice to select a healthy Mediterranean dietary pattern with no caloric restriction

Participants will complete measurement visits at baseline (-14 days), 3 mos, 6.5 mos, and 10 mos

Participants will complete a total of 23 intervention sessions over an approximately 10-and-a-half month period (Eight in person sessions and 15 telephone check-ins)

Participants will be randomized to one of the three diets for a minimum of a three-and-a-half month period. Re-randomization is possible following the 3 month and/or 6.5 month measurement visits. Re-randomization is based on acceptability of diet (self-report), non-severe hypoglycemic events (self-report), and not achieving significant weight change (defined as losing at least 2% of body weight from previous study visit), and worsening glycemic control (increase in Hemoglobin A1c of >/= 0.5% from previous study visit). Re-randomization will occur after the 14-day CGM wear period that will be initiated at each measurement visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
This initial pilot and feasibility study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management. The study will be done at UNC and Stanford. Sequential randomization will occur at 0, 3.5, and 7 months. Following the baseline measurement visit and two week run-in period, participants will be randomized to one of three diets (stratified by site with block size of 4). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the assigned diet is not acceptable or effective will be re-randomized (or re-assigned if only one diet remains untried). 10.5 months of follow-up time allows for evaluation of the effect of diets on initial weight loss and on early maintenance of initial weight loss. Decision criteria for re-randomization will incorporate clinical outcomes (glycemic control and weight change) and acceptability of the diet.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Overweight and Obesity
Intervention  ICMJE
  • Behavioral: Hypocaloric, low carbohydrate diet
    Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
    Other Name: Low carbohydrate diet
  • Behavioral: Hypocaloric, moderate low fat diet
    Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
    Other Name: Low fat diet
  • Behavioral: Mediterranean diet, no caloric restriction
    Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
    Other Name: Mediterranean diet
Study Arms  ICMJE
  • Experimental: Hypocaloric, low carbohydrate
    Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
    Intervention: Behavioral: Hypocaloric, low carbohydrate diet
  • Experimental: Hypocaloric, moderate low fat
    Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
    Intervention: Behavioral: Hypocaloric, moderate low fat diet
  • Experimental: Mediterranean, no caloric restriction
    Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
    Intervention: Behavioral: Mediterranean diet, no caloric restriction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2018)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals 19-30 years old at enrollment
  • History of Type 1 diabetes for greater than one year
  • Latest hemoglobin A1c less than 13%
  • BMI of 27-39

Exclusion Criteria:

  • Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
  • Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
  • Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
  • Individuals unwilling to follow any of the three study diets
  • Individuals who monitor blood glucose less than 3 times a day
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joan M Thomas, MS, RD 919-843-8423 joan_thomas@unc.edu
Contact: Katie Souris, MPH 919-966-5635 kjsouris@unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03651622
Other Study ID Numbers  ICMJE 18-1025
1DP3DK113358-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Elizabeth Mayer-Davis, PhD UNC Chapel Hill
Principal Investigator: David M Maahs, MD, PhD Stanford University
Principal Investigator: Richard Pratley, MD Florida Hospital, Translational Research Institute
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP