ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 19 - 30 |
| Updated: | 1/11/2019 |
| Start Date: | November 12, 2018 |
| End Date: | September 2020 |
| Contact: | Joan M Thomas, MS, RD |
| Email: | joan_thomas@unc.edu |
| Phone: | 919-843-8423 |
Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes
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.
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.
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.
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.
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
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Elizabeth J Mayer-Davis, PhD
Phone: 919-966-5635
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Palo Alto, California 94304
Principal Investigator: David Maahs, MD, PhD
Phone: 513-910-0081
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