Motivation Techniques for Sedentary Lifestyle and Obesity

Overseen By Rachel C Lyons, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Cognitive disability, Medical conditions, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

280 Participants Needed

Trial Summary

What is the purpose of this trial?

This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for sedentary lifestyle and obesity?

Research shows that mobile health (mHealth) interventions, like smartphone apps, can help reduce sedentary time and promote physical activity in people with obesity. These interventions have been found to increase physical activity levels and improve engagement in weight loss efforts, suggesting they can be effective in addressing sedentary lifestyles and obesity. ^{1 2 3 4 5}

Is the mHealth Physical Activity Program safe for humans?

The research suggests that using mobile health (mHealth) interventions, like smartphone apps and electronic activity monitors, is generally safe for promoting physical activity and reducing sedentary behavior in humans. These interventions have been used in various studies without reports of significant safety concerns. ^{1 6 7 8 9}

How does the Physical Activity Goals mHealth Intervention differ from other treatments for sedentary lifestyle and obesity?

The Physical Activity Goals mHealth Intervention is unique because it uses mobile health technology to set personalized physical activity goals and provide real-time feedback, which can be more engaging and accessible than traditional methods. This approach leverages digital behavior change techniques like goal setting and self-monitoring, making it distinct from other treatments that may not utilize technology to the same extent. ^{1 4 10 11 12}

Research Team

Genevieve F Dunton, PhD MPH

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for inactive adults who are overweight or obese. It aims to understand how emotions and feelings affect their physical activity levels. The details about specific inclusion and exclusion criteria are not provided, but typically these would outline the exact requirements participants need to meet in order to take part.

Inclusion Criteria

Self-reported BMI ≥ 25

Reside in an area with Internet or Wi-Fi connectivity during the study period

Current structured physical activity engagement < 60 minutes per week

Exclusion Criteria

I cannot give informed consent because of a cognitive disability.

I cannot participate in certain activities or use a smartwatch for health tracking.

Current pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive affect-based or intensity-based goals for 8 weeks, followed by a crossover to the alternate goal type for another 8 weeks. Enhancements such as SAVOR and TYPE/CONTEXT may be included.

16 weeks

Follow-up

Participants are monitored for changes in physical activity behavior and affective mechanisms after the intervention.

4 weeks

Treatment Details

Interventions

• Physical Activity Goals mHealth Intervention
• SAVOR enhancement
• TYPE/CONTEXT enhancement

Trial Overview The eMOTION trial is testing three strategies: TYPE/CONTEXT enhancement, SAVOR enhancement, and a mobile health intervention setting physical activity goals. These approaches aim to improve emotional responses associated with exercise in hopes of increasing physical activity.

Participant Groups

Group I: Intensity > Affect (no enhancements) Experimental Treatment 1 Intervention

Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention.

Group II: Affect (no enhancements) > Intensity Experimental Treatment 1 Intervention

Participants receive affect-based goals for the first 8-weeks, then cross-over to receive intensity-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention.

Group III: Affect (+ SAVOR + TYPE/CONTEXT) > Intensity Active Control 3 Interventions

Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.

Group IV: Affect (+TYPE/CONTEXT) > Intensity Active Control 2 Interventions

Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.

Group V: Intensity > Affect (+ SAVOR + TYPE/CONTEXT) Active Control 3 Interventions

Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition.

Group VI: Affect (+SAVOR) > Intensity Active Control 2 Interventions

Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.

Group VII: Intensity > Affect (+SAVOR) Active Control 2 Interventions

Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition.

Group VIII: Intensity > Affect (+TYPE/CONTEXT) Active Control 2 Interventions

Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A smartphone-based intervention effectively reduced sedentary time (SED) in overweight/obese individuals, with participants showing significant decreases in SED and increases in light and moderate-to-vigorous physical activity after using three different prompting conditions.

The most effective approach was prompting 3-minute activity breaks after 30 minutes of sedentary time, which led to the greatest reduction in SED and increase in light physical activity compared to longer break conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B-MOBILE--a smartphone-based intervention to reduce sedentary time in overweight/obese individuals: a within-subjects experimental trial. Bond, DS., Thomas, JG., Raynor, HA., et al.[2022]

Inpatient rehabilitation for obesity should involve a multidisciplinary team, including various health professionals, to effectively improve weight loss and address related health issues.

Internet-based and mobile health (mHealth) technologies can enhance long-term obesity rehabilitation by improving treatment compliance and engagement, suggesting a promising direction for future research in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and outpatient rehabilitation using mobile technologies: the potential mHealth approach. Castelnuovo, G., Manzoni, GM., Pietrabissa, G., et al.[2022]

In the CITY trial, which involved 242 participants over 24 months, higher engagement with a smartphone app was associated with greater weight loss compared to personal coaching, particularly in the first 6 months.

Despite initial high engagement, usage of the app and its components dropped significantly over time, suggesting that more flexible prompting strategies may be needed to maintain participant engagement throughout the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial. Lin, PH., Grambow, S., Intille, S., et al.[2019]

A systematic review of 18 studies found that eHealth interventions, such as web-based programs and physical activity monitors, can effectively promote physical activity in adults with obesity.

The review highlighted that techniques like self-monitoring, which are effective in traditional face-to-face settings, can be more efficiently implemented through eHealth technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of eHealth Interventions to Promote Physical Activity in Adults with Obesity or Overweight. Lee, S., Patel, P., Myers, ND., et al.[2023]

Mobile app-based interventions can lead to a small increase in physical activity, with participants taking about 1,579 more steps compared to those with no intervention and 666 more steps compared to traditional methods, based on a review of 11 studies.

However, traditional interventions were found to be more effective in improving self-efficacy related to physical activity, indicating that while apps can help increase activity levels, they may not boost confidence as effectively as conventional approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Applications Running on Smartphones to Promote Physical Activity: A Systematic Review with Meta-Analysis. Silva, AG., Simões, P., Queirós, A., et al.[2020]

Electronic Activity Monitor Systems (EAMSs) show promise in increasing physical activity and reducing weight, with significant improvements noted in several studies, particularly in five out of nine studies for physical activity and four out of five for weight loss.

While EAMS interventions appear feasible and have higher participant retention rates, their efficacy compared to other interventions remains unclear, highlighting the need for more high-quality randomized controlled trials to better understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an electronic activity monitor system as an intervention modality: A systematic review. Lewis, ZH., Lyons, EJ., Jarvis, JM., et al.[2022]

A review of 22 studies on electronic activity monitor systems (EAMSs) showed that they can effectively enhance physical activity and weight loss in nonclinical populations, particularly when used for 6 weeks to 12 months.

Interventions that included multiple features of EAMSs, along with additional support like personal coaching, led to better health outcomes, but simply adding EAMSs to existing programs without unique components did not significantly improve results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the Use of an Electronic Activity Monitor System as a Component of Physical Activity and Weight-Loss Interventions in Nonclinical Populations: A Systematic Review. Sypes, EE., Newton, G., Lewis, ZH.[2020]

Smartphone-based mHealth interventions for promoting physical activity have shown promising results in changing behavior, but the evidence is primarily focused on adults, with only 24 out of 148 studies targeting adolescents.

There is a lack of standardized evaluation frameworks and behavior change theories in the development and reporting of these interventions, suggesting that improving systematic approaches could enhance their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Interventions for Physical Activity Promotion: Scoping Review of the Evidence Over the Last 10 Years. Domin, A., Spruijt-Metz, D., Theisen, D., et al.[2021]

A study involving 51 young participants (ages 14-17) tested two smartphone apps aimed at improving physical activity and cardiorespiratory fitness over 8 weeks, but neither app showed a significant effect on fitness levels compared to a control group.

Despite the lack of significant results, the high retention rate (96%) and interest in using physical activity apps suggest they could play a valuable role in future strategies to promote fitness and combat insufficient physical activity among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial. Direito, A., Jiang, Y., Whittaker, R., et al.[2022]

A systematic review of 18 randomized clinical trials involving 2298 sedentary individuals found that digital behavior change interventions (DBCIs) effectively improve physical activity and reduce sedentary behavior, with follow-up durations ranging from 5 weeks to 3 years.

The most frequently employed behavior change techniques (BCTs) in these interventions included goal setting, self-monitoring, and social support, indicating that structured planning and feedback are key components for success in modifying sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques and the Effects Associated With Digital Behavior Change Interventions in Sedentary Behavior in the Clinical Population: A Systematic Review. Martín-Martín, J., Roldán-Jiménez, C., De-Torres, I., et al.[2021]

Standalone gamified smartphone applications can lead to a small-to-moderate increase in physical activity, as shown by a meta-analysis of 19 studies involving 24 different applications.

The analysis revealed a standardized mean difference of 0.34 for randomized controlled trials and 0.38 for pre-to-post interventions, indicating that these applications can be effective tools for promoting physical activity among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Gamified Smartphone Applications on Physical Activity: A Systematic Review and Meta-Analysis. Yang, Y., Hu, H., Koenigstorfer, J.[2022]

The ProActive trial is evaluating a year-long intervention program designed to increase physical activity among 365 individuals aged 30-50 who are at risk of diabetes due to a family history, using methods like goal setting and self-regulatory skills.

This study is significant as it is the first to focus on a high-risk group in primary care, aiming to provide objective measurements of physical activity and potentially inform future health interventions for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ProActive trial protocol - a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766]. Williams, K., Prevost, AT., Griffin, S., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

B-MOBILE--a smartphone-based intervention to reduce sedentary time in overweight/obese individuals: a within-subjects experimental trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Obesity and outpatient rehabilitation using mobile technologies: the potential mHealth approach. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of eHealth Interventions to Promote Physical Activity in Adults with Obesity or Overweight. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Applications Running on Smartphones to Promote Physical Activity: A Systematic Review with Meta-Analysis. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Using an electronic activity monitor system as an intervention modality: A systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Investigating the Use of an Electronic Activity Monitor System as a Component of Physical Activity and Weight-Loss Interventions in Nonclinical Populations: A Systematic Review. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Smartphone-Based Interventions for Physical Activity Promotion: Scoping Review of the Evidence Over the Last 10 Years. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques and the Effects Associated With Digital Behavior Change Interventions in Sedentary Behavior in the Clinical Population: A Systematic Review. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Gamified Smartphone Applications on Physical Activity: A Systematic Review and Meta-Analysis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The ProActive trial protocol - a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766]. [2018]