NCT06570642

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2024Jun 2027

Study Start

First participant enrolled

August 14, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

August 16, 2024

Last Update Submit

June 23, 2025

Conditions

Keywords

Affective ResponsePsychological NeedsPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Physical Activity: Step Count

    Daily steps will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.

    Daily total for weeks 1-19

  • Physical Activity: Minutes

    Daily minutes of light, moderate, and vigorous physical activity will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.

    Daily total for weeks 1-19

Secondary Outcomes (3)

  • Affective Response

    Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19

  • Affectively-Charged Motivations

    Up to once daily for weeks 2-9 and weeks 12-19

  • Anticipated Affect

    Up to once daily for weeks 2-9 and weeks 12-19

Study Arms (8)

Affect (no enhancements) > Intensity

EXPERIMENTAL

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.

Behavioral: Physical Activity Goals mHealth Intervention

Intensity > Affect (no enhancements)

EXPERIMENTAL

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.

Behavioral: Physical Activity Goals mHealth Intervention

Affect (+ SAVOR + TYPE/CONTEXT) > Intensity

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Goals mHealth InterventionBehavioral: TYPE/CONTEXT enhancementBehavioral: SAVOR enhancement

Intensity > Affect (+ SAVOR + TYPE/CONTEXT)

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Goals mHealth InterventionBehavioral: TYPE/CONTEXT enhancementBehavioral: SAVOR enhancement

Affect (+SAVOR) > Intensity

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Goals mHealth InterventionBehavioral: SAVOR enhancement

Intensity > Affect (+SAVOR)

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Goals mHealth InterventionBehavioral: SAVOR enhancement

Affect (+TYPE/CONTEXT) > Intensity

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Goals mHealth InterventionBehavioral: TYPE/CONTEXT enhancement

Intensity > Affect (+TYPE/CONTEXT)

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Goals mHealth InterventionBehavioral: TYPE/CONTEXT enhancement

Interventions

On days participants plan to exercise, they engage in two daily goal sessions (morning and evening). Morning sessions provide an activity goal for the day and ask the participant to create a plan, anticipate barriers, and brainstorm solutions for achieving this goal. The affect-based goal condition asks participants to engage in either (1) a type (50% of daily goals) or (2) a context (50% of daily goals) of physical activity that allows them to experience positive affect. Goals focused on context are randomly generated to suggest that the participant performs activity (1) in a place; (2) in a social situation; or (3) while listening to something that makes them feel good. The intensity-based goal condition asks participants to maintain a certain target heart rate range during physical activity. Starting heart rate reflects the approximate age-adjusted heart rate max, with goals progressively increasing from 55% to 70% heart rate max.

Affect (+ SAVOR + TYPE/CONTEXT) > IntensityAffect (+SAVOR) > IntensityAffect (+TYPE/CONTEXT) > IntensityAffect (no enhancements) > IntensityIntensity > Affect (+ SAVOR + TYPE/CONTEXT)Intensity > Affect (+SAVOR)Intensity > Affect (+TYPE/CONTEXT)Intensity > Affect (no enhancements)

TYPE/CONTEXT augments intervention effects by providing tailored recommendations for activity types and contexts that satisfy personally-important psychological needs as rated by each participant at baseline. Ratings from a crowdsourced panel of adults on Amazon Mechanical Turk will be used to determine the potential for specific activity types and contexts to satisfy psychological needs; our tailoring algorithm will then recommend the corresponding activity type or context while accounting for reported constraints (e.g., ability, access). These details will be incorporated into a tailored recommendation provided to participants each Sunday as they make activity plans for the upcoming week. Specifically, the program will randomly select either type or context (i.e., location, audio, social) recommendations and will rotate every two weeks. For TYPE, participants' top 3 activity types are recommended; for CONTEXT, participants' top 3 activity contexts are recommended.

Affect (+ SAVOR + TYPE/CONTEXT) > IntensityAffect (+TYPE/CONTEXT) > IntensityIntensity > Affect (+ SAVOR + TYPE/CONTEXT)Intensity > Affect (+TYPE/CONTEXT)

SAVOR implements a brief savoring exercise on the smartphone that takes place either after the planned physical activity session or during the evening goal session (after the self-monitoring module). Participants will respond to questions that are intended to enhance and prolong positive experiences during physical activity. To trigger attentional deployment, a common savoring strategy that involves intensifying experiences by focusing on them, participants will answer three open-ended prompts. These prompts are drawn from a prompt pool with slightly varied wording to promote a sense of novelty. Savoring prompts will rotate daily and have a day lag built in every week (i.e., Week 1 Monday Savoring Prompts are Week 2 Tuesday Savoring Prompts).

Affect (+ SAVOR + TYPE/CONTEXT) > IntensityAffect (+SAVOR) > IntensityIntensity > Affect (+ SAVOR + TYPE/CONTEXT)Intensity > Affect (+SAVOR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥ 18 years
  • Reside in the United States
  • Self-reported BMI ≥ 25
  • Current structured physical activity engagement \< 60 minutes per week
  • Own a personal smartphone device
  • Reside in an area with Internet or Wi-Fi connectivity during the study period
  • Able to speak and read in English
  • Interested and willing to start a physical activity program
  • Willing to wear a Fitbit Versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any Fitbits or smartwatches previously worn, for the duration of the study period
  • Able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen

You may not qualify if:

  • Inability to provide informed consent due to cognitive disability
  • Inability to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist or answer brief surveys on the smartwatch for any reason
  • Current pregnancy
  • Referred to the study by another participant or from Reddit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

RECRUITING

Related Publications (1)

  • Dunton GF, Hatzinger L, Crosley-Lyons R, Hewus M, Wang WL, Van Dyck D, Huh J. Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study. Contemp Clin Trials. 2025 Jul;154:107945. doi: 10.1016/j.cct.2025.107945. Epub 2025 May 12.

MeSH Terms

Conditions

Sedentary BehaviorOverweightObesityNeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Genevieve F Dunton, PhD MPH

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Micaela Hewus, MPH

CONTACT

Rachel C Lyons, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: The study will use a partial factorial, crossover, within x between subjects design. Participants randomly receive affect- or intensity-based goals for 8-weeks (Part 1), followed by a 2-week washout period, then cross-over to the other condition for 8-weeks (Part 2). During the affect-based goal condition, participants randomly receive one of four combinations of intervention enhancements: TYPE/CONTEXT (with vs. without) x SAVOR (with vs. without). In summary, participants are randomly assigned to one of eight groups based on order and intervention components: (1) intensity \> affect without enhancements; (2) intensity \> affect with TYPE/CONTEXT; (3) intensity \> affect with SAVOR; (4) intensity \> affect with both TYPE/CONTEXT and SAVOR; (5) affect without enhancements \> intensity; (6) affect with TYPE/CONTEXT \> intensity; (7) affect with SAVOR \> intensity; and (8) affect with both TYPE/CONTEXT and SAVOR \> intensity.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Health Behavior Research and Director, USC Real-Time Eating Activity and Children's Health (REACH) Lab

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 26, 2024

Study Start

August 14, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations