Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes

NCT03650088 | Completed Results

• 1 other identifier: 18-1078
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to 1) adapt a weight loss app that the Tate team has previously developed to promote PA and diet and adapt them to the needs and perspectives of those with Type 2 Diabetes (T2DM), integrate daily monitoring of BG using continuous monitoring (CGM) and self-monitoring of diet using the simplified system, and develop appropriate displays of data to facilitate comprehension and decision making, 2) develop the modified intervention and, 3) conduct a pilot and feasibility study on short-term impacts of the intervention in overweight adult patients with T2DM not treated with medications in preparation for an R01 submission.

Conditions

Diabetes Mellitus, Type 2; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Weight will be measured on a digital scale

  Baseline, Month 3

Secondary Outcomes (4)

• Change in Body Mass Index (BMI)

  Baseline, Month 3

• Change in HbA1c Percent

  Baseline, Month 3

• Change in Compliance Behavior and Efforts at Diabetes Self-control

  Baseline, Month 3

• Change in Diabetes-related Quality of Life: The Diabetes Obstacles Questionnaire (DOQ-30)

  Baseline, Month 3

Study Arms (1)

Weight Loss Intervention

EXPERIMENTAL

Behavioral weight loss program with digital tools including smartphone app for dietary self-monitoring using a 'traffic light' approach, physical activity tracker, smart scale, and blood glucose monitoring plus with weekly consultation (in person or phone) with an interventionist for behavioral lessons and supports.

Behavioral: Behavioral weight loss with digital tools

Interventions

Behavioral weight loss with digital tools BEHAVIORAL

Participants will monitor their diet in a study smart phone app using a 'traffic light' approach where foods are categorized as red (high fat and/or calorie), yellow (moderate fat/calorie, high nutrient), or green (low fat/calorie, high nutrient) and adhere to a red food limit recommendation, weigh daily on a digital scale whose data syncs to the study app, gradually increase physical activity and track it using a wearable device for which data is also synced to the app, and monitor blood glucose using Continuous Glucose Monitoring. Participants will meet weekly with a trained interventionist for behavioral lessons (adapted from Diabetes Prevention Program curriculum) and counseling.

Weight Loss Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Type 2 diabetes managed with lifestyle or pre-diabetes
• HBA1c \>= 5.7%
• BMI 25 - 40 kg/m\^2
• English speaking and writing
• not adhering the American College of Sports Medicine recommendation of 150 minutes of MVPA/week
• have a smartphone with internet access

You may not qualify if:

• current participation in another physical activity or weight control program
• report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)
• substance abuse or mental health problems that would make it difficult to adhere to the dietary prescription
• moving out of the area during the study period
• unable to attend weekly sessions
• diagnosis of an eating disorder such as bulimia or anorexia
• currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Michigan: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Deborah F. Tate, PhD
• Organization: University of North Carolina at Chapel Hill

dtate@unc.edu

919-966-5851

Study Officials

• Deborah F. Tate, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: October 20, 2019
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: January 13, 2023
• Results First Posted: January 13, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)