Overweight and/or Obesity
Conditions
Keywords
Behavioral intervention, Weight loss, mHealth intervention
Brief summary
The goal of this study is to learn if integrating a chatbot into an existing 12-week smartphone-delivered behavioral weight loss program is feasible and effective for weight loss among young adults. Researchers will compare a standard behavioral weight loss program for young adults that delivers 1-2 brief messages per day (AGILE) to the same program with a chatbot that offers additional behavior change support integrated into the app (AGILE + Chatbot) to determine if the program with the chatbot is feasible, acceptable to participants, and improves program engagement and weight change compared to AGILE alone.
Detailed description
At baseline, 20 young adults, ages 18-39, with overweight or obesity, will be randomized to either the AGILE or AGILE + Chatbot group. Participants in both groups will receive a 12-week mobile behavioral weight loss intervention (AGILE) delivered via the study smartphone application. The weight loss intervention includes weekly evidence-based lessons; personalized goals; self-monitoring of diet, activity, and weight; weekly tailored feedback on progress; and brief, tailored messages 1-2 times per day displayed in the study smartphone app. Participants in the AGILE group will receive no additional program features. Participants in the AGILE + Chatbot group will have a version of the smartphone app with an integrated chatbot. The chatbot will be available for brief conversations 1-2 times per day. Assessments will occur at baseline and 12 weeks.
Interventions
BEHAVIORALAGILE Intervention
12-week behavioral weight loss intervention that includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; and 1-2 intervention messages per day that are tailored based on current diet, activity, and/or weight progress. Participants receive a Fitbit activity tracker and scale and track their activity and weight in the Fitbit app. Participants use a simplified approach to self-monitoring their dietary intake by tracking 'red' (high calorie) foods in the study's food log smartphone app. This data is used to inform the daily intervention messages and weekly tailored feedback.
BEHAVIORALChatbot
The AGILE chatbot operates via a trained generative artificial intelligence large language model and offers additional support to participants for making changes in their dietary and physical activity behaviors. The chatbot is available for conversation only after a message has been delivered in the AGILE app. Participants can choose to start a conversation or not, and the ability to start a conversation expires at midnight. The chatbot is able to provide evidence-based cognitive behavioral support to participants including, but not limited to: 1) strategies and tips for dietary self-monitoring, physical activity tracking (wearing the Fitbit), and self-weighing; 2) overcoming common barriers to dietary and physical activity goal achievement; 3) general support for remaining engaged in behavior change efforts during the course of the program.
Sponsors
University of North Carolina, Chapel Hill
UNC Gillings School of Global Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* body mass index (BMI) of 25-45 kg/m\^2 * English-speaking and writing * own an iPhone with a data plan * willing to be randomized to either treatment group
Exclusion criteria
* Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes * Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including tuberculosis, currently receiving cancer treatment, or history of a heart attack or stroke * 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), or report any other reason not able to walk for physical activity * Lost 10 or more pounds (and kept it off) in the last 6 months * Currently taking weight loss medications * History of weight loss surgery or planning weight loss surgery in the next 4 months * Report a past diagnosis of, or receiving treatment for, a DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) eating disorder (anorexia nervosa or bulimia nervosa) * Currently pregnant or planning to become pregnant within the next 4 months * Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including history of or diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, current diagnosis of alcohol or substance abuse * Another member of the household is a participant or staff member on this trial * Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study * Not willing to wear a Fitbit every day * Have participated in another study conducted by the UNC Weight Research Program within the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program engagement | up to 12 weeks | Program engagement is defined as the mean percent of days in which participants accessed the AGILE app. |
| Chatbot engagement | up to 12 weeks | Chatbot engagement is defined as the mean percent of days in which participants started a conversation with the chatbot. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability - Perceived usefulness of chatbot | 12 weeks | Perceived usefulness (PU) of the chatbot is measured by the Perceived Usefulness subscale of the Technology Acceptance Model Questionnaire. This subscale includes four items that assess usefulness of the chatbot within the AGILE program that are scored on a Likert scale of 1 = Strongly disagree to 7 = Strongly agree. A composite score is calculated by taking an average of the four items. Higher values on the composite PU score represent a greater perceived usefulness of the chatbot. |
| Acceptability - Perceived ease of use of chatbot | 12 weeks | Perceived ease of use (EU) of the chatbot is measured by the Perceived Ease of Use subscale of the Technology Acceptance Model Questionnaire. This subscale includes six items that assess how easy it is to use the chatbot within the AGILE program that are scored on a Likert scale of 1 = Strongly disagree to 7 = Strongly agree. A composite score is calculated by taking an average of the six items. Higher values on the composite EU score represent a greater perceived ease of use of the chatbot. |
| Percent weight change | Baseline, Week 12 | Percent weight change is defined as weight change from baseline to 12 weeks, calculated as \[(weight at 12 weeks - baseline weight) / baseline weight\] × 100 |
Countries
United States
Contacts
CONTACTBrooke T Nezami, PhD
CONTACTKaren Hatley, MPH
PRINCIPAL_INVESTIGATORBrooke T Nezami, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed