- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06245369
SWITCH Diets Study: Self-monitoring With Internet Technology to Choose Healthy Diets (SWITCH)
Self-monitoring With Internet Technology to Choose Healthy Diets Study
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carolina Delgado-Diaz, PhD
- Phone Number: 803-576-5688
- Email: delgadoc@mailbox.sc.edu
Study Contact Backup
- Name: Brie Turner-McGrievy, PhD
- Phone Number: 803-777-3932
- Email: brie@sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- Recruiting
- Prevention Research Center, University of South Carolina
-
Contact:
- Brie Turner-McGrievy, PhD
- Email: brie@sc.edu
-
Contact:
- Carolina Delgado-Diaz, PhD
- Email: delgadoc@mailbox.sc.edu
-
Principal Investigator:
- Brie Turner-McGrievy, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SWITCH tracking healthy nutrients
Participants allocated to this group will be given goals to reach a recommended daily intake of nutrients in which US adults tend to not consume enough.
Recommended amounts will be based off of age and sex, in line with the US Dietary Guidelines.
|
Behavioral: Participants will have access to a weekly learning module created as Kahoot courses. Each module will include some or all (as applicable) of the following:
Behavioral: Diet (track by in app database). App homepage displays dietary intake graph -circles -. Participants will see an empty circles for the goal nutrients at the start of each day, which will fill up as the participant tracks his/her food intake. If the participant consumes an excess beyond the nutrient intake goal, the circle will remain entirely full. |
Active Comparator: standard SWITCH app
Participants in this group will be given goals to reduce intake of nutrients in which US adults tend to consume too much.
Personalized daily intake goals for nutrients will be based on age, weight, sex, and the US Dietary Guidelines.
|
Behavioral: Participants will have access to a weekly learning module created as Kahoot courses. Each module will include some or all (as applicable) of the following:
Diet (track by in app database). App homepage displays dietary intake graph -circles -. Participants allocated to the control group, tracking intake of nutrients to lower, will see a full circle at the start of each day which depletes, or empties, as the participant tracks his/her food intake. If the participant consumes an excess beyond the nutrient intake goal, the circle will remain entirely empty and the reported totals below the intake circles will display the current intake totals. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Healthy Eating Index
Time Frame: 12 weeks
|
Change in Healthy Eating Index from baseline to 12 weeks as assessed by dietary recalls.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body weight
Time Frame: 12 weeks
|
Change in Body weight assessed by home scale - self-report data confirmed by photo
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brie Turner-McGrievy, PhD, University of South Carolina
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00132921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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