Digital Interventions for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to make digital health tools more accessible for individuals dealing with obesity. It tests various digital approaches, such as text messaging and phone calls, to support healthy lifestyle changes. Participants will join groups to try different combinations of these tools, including Ask-Advise-Connect (AAC) and Connect Only (CO), to determine their effectiveness. Individuals with a Body Mass Index (BMI) of 30 or higher who own a cell phone might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative digital health solutions for obesity management.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these digital interventions for obesity are safe?
Previous studies have used the Ask-Advise-Connect (AAC) method safely to help people quit smoking, without causing harmful side effects. This suggests it might also be safe for other uses, such as weight loss.
For the Text Messaging (TM) component, research shows that using text messages to support weight loss is generally safe. In these studies, most participants found the messages helpful and did not experience negative effects.
The Continued TM plus Motivation And Problem Solving (TM+MAPS) approach, which combines phone calls with text messages, is also considered safe according to research. Participants did not report adverse effects with this method.
Overall, these treatments have been well-tolerated in their respective studies, indicating they are likely safe for those considering joining a clinical trial for weight loss.12345Why are researchers excited about this trial?
Researchers are excited about the Digital Interventions for Obesity trial because it explores innovative ways to tackle obesity using technology-based support. Unlike traditional treatments like diet plans and exercise regimens, these interventions focus on digital connectivity and personalized communication. Ask-Advise-Connect (AAC) integrates with clinical settings to provide tailored advice, while the Text Messaging (TM) component ensures ongoing support through regular, bidirectional messages. The inclusion of Motivation And Problem Solving (TM+MAPS) offers additional encouragement through brief calls, potentially enhancing patient commitment and success. These digital strategies aim to make weight management more accessible and sustainable, breaking away from conventional approaches.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that digital tools can help manage obesity. In this trial, the Ask-Advise-Connect (AAC) method is one of the interventions tested. It has successfully linked people to treatment, with one study showing increased enrollment of smokers in treatment programs. Although this study focused on smoking cessation, the straightforward process might also aid those seeking weight loss. Another arm of this trial tests Text Messaging (TM), which has supported weight loss, with some studies noting significant weight loss in participants who followed the program. Additionally, the trial evaluates the effectiveness of adding Continued TM plus Motivation And Problem Solving (TM+MAPS), which provides extra support through motivational texts and calls, helping people stay engaged and manage their weight. These digital tools use technology to overcome obstacles, making them promising options for treating obesity.36789
Who Is on the Research Team?
Chelsey Schlechter, PhD
Principal Investigator
Huntsman Cancer Institute/ University of Utah
Are You a Good Fit for This Trial?
This trial is for adults (18+) with obesity (BMI of 30 or higher) who visit participating community health clinics, have a valid cell phone number on record, haven't opted out of clinic text messages, and speak English or Spanish.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Usual Care
Participants receive usual care before the implementation of AAC
AAC Implementation
Ask-Advise-Connect (AAC) is implemented across clinics and evaluated using a stepped wedge design
Follow-up
Participants are monitored for engagement and effectiveness of EBIs
What Are the Treatments Tested in This Trial?
Interventions
- Ask-Advise-Connect (AAC)
- Connect Only (CO)
- Continued TM plus Motivation And Problem Solving (TM+MAPS)
- Text Messaging (TM)
- TM-Continued (TM-Cont)
Trial Overview
The study compares different digital support strategies to help patients manage obesity. These include motivational text messages, problem-solving support, and ways to connect patients with weight management programs. Participants are randomly assigned to these approaches.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
Ask-Advise-Connect (AAC) will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all). TM Continued (TM-Cont) will consist of a monthly text message that includes a simple one-touch response to connect during months 6-12 following each individual's clinic visit (i.e., up to 6 texts).
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with UC for 3 months, then AAC for 9 months during the SW Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (up to 6 texts). Continued TM plus Motivation And Problem Solving (TM+MAPS) will consist of a monthly text message plus up to 2 brief telephone calls from patient navigators during months 6-12 following each individual's clinic visit (up to 6 texts and 2 calls).
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. Text Messaging (TM) consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all).
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. A Clinic-level implementation strategy only (CO) for the 12 months following each individual's clinic visit.
No patient level implementation strategy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Association for Utah Community Health (AUCH)
Collaborator
Citations
The implementation of ask-advise-connect in a federally ...
This study is the first to evaluate clinic staff and leadership perceptions of Ask-Advise-Connect (AAC), which seamlessly connects smokers in healthcare ...
The Ask–Advise–Connect Approach for Smokers in a ...
This study evaluated the efficacy of the Ask–Advise–Connect (AAC) approach to linking smokers with treatment in a large, safety net public healthcare system.
3.
moqc.org
moqc.org/wp-content/uploads/2017/08/Ask-Advise-Connect-Concept_JAMA-Internal-Medicine-2013.pdfAsk-Advise-Connect
OUTCOMES: REACH, EFFICACY, AND IMPACT. The RE-AIM conceptual framework15 was used to evaluate the reach, efficacy, and impact of the AAC and AAR approaches.
4.
naquitline.org
naquitline.org/news/637805/The-Implementation-of-Ask-advise-connect-in-a-Federally-Qualified-Health-Center-a-Mixed-Methods-Eva.htmof Ask-advise-connect in a Federally Qualified Health Center
Quantitative patient-level outcomes of reach, effectiveness, and impact were calculated. Findings have implications for streamlining ...
Ask-Advise-Connect | Request PDF
Data were from a 34-month (April 2013–February 2016) one-group implementation trial that evaluated the Ask-Advise-Connect (AAC) approach to ...
Efficacy of Ask Advise Connect in a Safety Net Healthcare ...
Data were collected between June 2010 and March 2012 and analyzed in 2012. Main Outcome Measure. The primary outcome – impact – was defined as the proportion of ...
quitline treatment engagement and smoking cessation outcomes
Smokers who enrolled in treatment via Ask Advise Connect reported abstinence rates that were consistent with other quitline treatment ...
8.
mdanderson.elsevierpure.com
mdanderson.elsevierpure.com/en/publications/the-ask-advise-connect-approach-for-smokers-in-a-safety-net-healt/The ask-advise-connect approach for smokers in a safety ...
This study evaluated the efficacy of the Ask-Advise-Connect (AAC) approach to linking smokers with treatment in a large, safety net public healthcare system.
Implementation of ask-advise-connect for smoking cessation ...
The Ask-Advise-Connect (AAC) approach can help primary care providers to increase the number of people who attempt to quit smoking and enrol ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.