Overweight and ObesitySWITCHNCT06245369
SWITCH Diets Study: Self-monitoring With Internet Technology to Choose Healthy Diets
A study testing learning modules (within app), SWITCH app (self-regulation features) - Experimental and SWITCH app (self-regulation features) - Comparator in people with Overweight and Obesity and Pre-diabetes, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Pre-diabetes
- What is being tested?
- learning modules (within app), SWITCH app (self-regulation features) - Experimental and SWITCH app (self-regulation features) - Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 18 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Research Center, University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Pre-diabetes
- Being tested
- learning modules (within app), SWITCH app (self-regulation features) - Experimental, SWITCH app (self-regulation features) - Comparator
- Keywords
- Healthy diet, obesity, mobile technology, self-monitoring
- Medical subject headings
- Overweight, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learning modules (within app)Behavioural
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 app (self-regulation features) - ExperimentalBehavioural
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 app (self-regulation features) - ComparatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: learning modules (within app); Behavioral: SWITCH app (self-regulation features) - Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Healthy Eating Index
Change in Healthy Eating Index from baseline to 12 weeks as assessed by dietary recalls.
Measured: 12 weeks
Secondary outcomes (1)
Change in Body weight
Change in Body weight assessed by home scale - self-report data confirmed by photo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Apr 2024
- Primary completion14 Feb 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie Turner-McGrievy, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245369
- Sponsor's protocol ID
- Pro00132921
- Acronym
- SWITCH
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-monitoring With Internet Technology to Choose Healthy Diets Study
- ClinicalTrials.gov ID
- NCT06245369
- Acronym / sponsor ID
- SWITCH / Pro00132921
- Conditions
- Overweight and Obesity, Pre-diabetes
- Keywords
- Healthy diet, obesity, mobile technology, self-monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWITCH tracking healthy nutrients | Experimental | Behavioral: learning modules (within app), Behavioral: SWITCH app (self-regulation features) - ExperimentalParticipants 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. |
| standard SWITCH app | Active comparator | Behavioral: learning modules (within app), Behavioral: SWITCH app (self-regulation features) - ComparatorParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| learning modules (within app)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 | Behavioural | SWITCH tracking healthy nutrients, standard SWITCH app |
| SWITCH app (self-regulation features) - ExperimentalBehavioral: 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. | Behavioural | SWITCH tracking healthy nutrients |
| SWITCH app (self-regulation features) - ComparatorDiet (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. | Behavioural | standard SWITCH app |
Primary outcome
Change in Healthy Eating Index
Time frame: 12 weeks
Change in Healthy Eating Index from baseline to 12 weeks as assessed by dietary recalls.
1 secondary outcome
Change in Body weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brie Turner-McGrievy, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing learning modules (within app), SWITCH app (self-regulation features) - Experimental and SWITCH app (self-regulation features) - Comparator in people with Overweight and Obesity and Pre-diabetes, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Healthy Eating Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.