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Advancing Care for Type 1 Diabetes and Obesity Network Study (ACT1ON)

University of North Carolina at Chapel Hill


Description

The goal of this research study is to help young adults with Type 1 diabetes improve both their blood sugar management and their weight at the same time. A total of 84 adults will participate in this study. If participating, you will be in this study for about ten and a half months. This study will compare three specific diets (low fat/reduced calorie, low carbohydrate/reduced calorie or a Mediterranean-based eating plan).


Keywords:

Auto Immune Diseases, Diabetes, Nutrition


Category:

Behavioral

Qualifications

 


Age
19 - 30 years


Gender
Any


Study Population

An estimated total of 84 young adults (age 19 - 30) who have been diagnosed with Type 1 diabetes for more than one year will participate in this study. A target of 42 individuals at the University of North Carolina at Chapel Hill (UNC-CH) and 42 individuals at Stanford will participate. Participants must have a most recent HbA1C under 13% and a body mass index (BMI) between 27 and 39.


Investigator

Elizabeth Mayer-Davis
Distinguished Professor
Nutrition Operations

For questions, contact:

Joan Thomas
joan_thomas@unc.edu
(919) 843-8423


Recruitment Period End

August 31, 2019

Location

Primary Location
UNC Hospitals Diabetes and Endocrinology Clinic at Meadowmont
300 Meadowmont Village Cir #202, Chapel Hill, NC 27517, USA
Secondary Location
UNC Applied Physiology Laboratory
101 Student Recreation Center #8610, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 19 - 30 years

Participant qualification(s) Inclusion criteria: Male and female individuals ages 19-30 years old with a diagnosis of Type 1 diabetes for greater than one year. Individuals must have HbA1c less than 13% and a BMI of 27-39.

Not eligible if: Exclusion criteria: The following individuals will be excluded from study participation: individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, existing strict dietary restrictions (e.g., vegan), or those with other serious condition that renders participation inappropriate. Individuals who have experienced DKA or severe hypoglycemia requiring outside assistance in the past 6 months will be excluded. Females who have given birth in the last 12 months, are currently pregnant, breastfeeding, or planning to become pregnant during the study period will be excluded. Individuals who are unwilling to follow any of the three study diets will be excluded. Individuals who self-monitor blood glucose less than three times a day will be excluded.

Number of Visits

    » 12 In person visit(s)

    4 measurement visits completed at two separate locations (UNC Hospitals Diabetes and Endocrinology Clinic at Meadowmont and the Applied Physiology Laboratory at UNC Chapel); 8 visits with a registered dietitian (RD) at UNC Chapel Hill

    » 30 Remote visit(s)

    15 Phone check-ins with study registered dietitian; 4 opportunities to complete online questionnaires ahead of measurement visits; 1 online questionnaire to assess study diet acceptability in between each measurement visit (total of 3)

Participation Period

10.5 months

Compensation

Participants will receive up to $750.00 in increments based on completion of study visits and activities. Compensation will be distributed as Visa gift cards.

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.