跳至主要内容
临床试验/NCT07534254
NCT07534254
招募中
不适用

Leveraging Generative Artificial Intelligence in Mobile Health Promotion Programs: A Use Case for Enhancing Tailored Messaging and Engagement in a Mobile Healthy Weight Program

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月23日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Program engagement

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Core Intervention

Experimental

Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application.

干预措施: AGILE Intervention (Behavioral)

Core Intervention with Chatbot

Experimental

Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.

干预措施: AGILE Intervention (Behavioral)

Core Intervention with Chatbot

Experimental

Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.

干预措施: Chatbot (Behavioral)

结局指标

主要结局

Program engagement

时间窗: up to 12 weeks

Program engagement is defined as the mean percent of days in which participants accessed the AGILE app.

Chatbot engagement

时间窗: up to 12 weeks

Chatbot engagement is defined as the mean percent of days in which participants started a conversation with the chatbot.

次要结局

  • Acceptability - Perceived usefulness of chatbot(12 weeks)
  • Acceptability - Perceived ease of use of chatbot(12 weeks)
  • Percent weight change(Baseline, Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验