NCT06245369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

January 29, 2024

Last Update Submit

March 18, 2025

Conditions

Keywords

Healthy diet, obesity, mobile technology, self-monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in Healthy Eating Index

    Change in Healthy Eating Index from baseline to 12 weeks as assessed by dietary recalls.

    12 weeks

Secondary Outcomes (1)

  • Change in Body weight

    12 weeks

Study Arms (2)

SWITCH tracking healthy nutrients

EXPERIMENTAL

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: learning modules (within app)Behavioral: SWITCH app (self-regulation features) - Experimental

standard SWITCH app

ACTIVE COMPARATOR

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: learning modules (within app)Behavioral: SWITCH app (self-regulation features) - Comparator

Interventions

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: * A brief educational video discussing the week's topic * A brief video sharing ideas for applying the educational content into daily life * PDF of "meal swap" examples * A weekly goal or challenge * Recipes

SWITCH tracking healthy nutrientsstandard SWITCH app

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.

SWITCH tracking healthy nutrients

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.

standard SWITCH app

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention Research Center, University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

OverweightObesityGlucose Intolerance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Brie Turner-McGrievy, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 7, 2024

Study Start

April 15, 2024

Primary Completion

February 14, 2025

Study Completion

March 18, 2025

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations