Clinical trial NCT06245369: SWITCH Diets Study: Self-monitoring With Internet Technology to Choose Healthy Diets
Official title: Self-monitoring With Internet Technology to Choose Healthy Diets Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Pre-diabetes
Keywords: Healthy diet, obesity, mobile technology, self-monitoring
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of the Self-monitoring With Internet Technology to Choose Healthy Diets (SWITCH) study is to examine a 12-week remotely delivered program designed to help adults adopt a healthy dietary lifestyle and lose weight in a diverse cohort of adults with overweight/obesity.

The intervention uses a self-determination theory framework to provide a deeper understanding of the factors that influence dietary behavior within the context of tracking. This study incorporates autonomy-supportive strategies to encourage participants to feel more in control of their dietary choices and will provide information and resources to boost participant's competence in achieving their dietary goals. The intervention includes weekly learning modules to support healthy eating and weight loss and daily dietary tracking with visual feedback, all accessible within the SWITCH app.

Detailed description: The SWITCH study is a 12-week remotely delivered, randomized behavioral intervention. Participants will be randomized to one of two groups: 1) SWITCH tracking nutrients to decrease (n=50) or 2) SWITCH tracking nutrients to increase (n=50). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at baseline and 12 weeks.

Intervention Design:

Diet tracking. Participants in both groups will be asked to track all meals, snacks, and beverages via the SWITCH app and complete a weekly learning module. Both groups will receive the same intervention, but the targeted nutrient goals and the in-app display of daily intake will differ between groups. Participants will be given goals to either increase certain nutrients or to decrease certain nutrients.

Diet related education to support healthy eating and weight loss will be provided each week within the SWITCH app. Each module includes some or all (as applicable) of the following components: A brief educational video discussing the week's topic, a video sharing ideas for applying the educational content into daily life, "meal swap" examples, a weekly goal or challenge and example recipes.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 64 years.
* BMI between 25 - 49.9 kg/m2
* Have 2 risk factors for T2DM in addition to having overweight or obesity (as defined by the NIDDK).
* Own and use a smartphone with a data plan.
* Must be willing and able to change dietary intake.
* Be free of major health or psychiatric diseases, drug, or alcohol dependency.
* Willing to sign informed consent.
* Own a digital body weight scale, have regular access, or be willing to purchase one

Exclusion Criteria:

* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months.
* Diagnosed with type 2 diabetes or currently using medications that may impact blood glucose.
* Pregnant (or have been pregnant in the last 6 months), anticipating becoming pregnant in the next 12 months, or currently breastfeeding.
* Having an eating disorder.

Primary outcomes:
measure: Change in Healthy Eating Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prevention Research Center, University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Brie Turner-McGrievy, PhD
role: PRINCIPAL_INVESTIGATOR
References: