Clinical trial · Interventional
eMOTION Formative Study
Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions: Formative Study
NCT06125964CI-TRIAL-00093612completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The eMOTION Study is a two-part ORBIT model phase 1 trial. The first part, called the Formative Study, will assess acceptability and feasibility of a novel physical activity intervention in adults at increased risk for cancer due to overweight or obesity.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Overweight or Obesity | — | UNRESOLVED | — |
| Physical Inactivity | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Affect-Based Goals | Behavioral | — | UNRESOLVED |
| Intensity-Based Goals | Behavioral | — | UNRESOLVED |
| SAVOR Enhancement | Behavioral | — | UNRESOLVED |
| TYPE/CONTEXT Enhancement | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Intensity
- description
- Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention.
- interventionNames
- Behavioral: Intensity-Based Goals
- type
- ACTIVE_COMPARATOR
- label
- Affect + TYPE/CONTEXT
- description
- Participants receive affect-based goals for two 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.
- interventionNames
- Behavioral: Affect-Based Goals
- Behavioral: TYPE/CONTEXT Enhancement
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adults aged ≥18 years * residing in the United States * self-reported BMI ≥ 25 * currently engaging in \< 60 minutes per week of structured physical activity * owning a personal smartphone device * residing 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 they previously wore, 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 Exclusion Criteria: * unable to provide informed consent due to cognitive disability * unable 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 for any reason * currently pregnant
References
Publications (2)
- DERIVEDHatzinger LA, Crosley-Lyons R, Hewus M, Wang WL, Huh J, Dyck DV, Dunton GF. Delivering and evaluating digital therapeutic interventions to increase physical activity: Formative testing of engagement, compliance, and adherence. Digit Health. 2026 Mar 24;12:20552076261435865. doi: 10.1177/20552076261435865. eCollection 2026 Jan-Dec. PMID 41889431
- DERIVEDCrosley-Lyons R, Hatzinger L, Hewus M, Wang WL, Van Dyck D, Huh J, Hekler E, Dunton GF. An Early-Stage Digital Therapeutic Intervention to Enhance Affective Response During Physical Activity Among Adults With Overweight or Obesity: Benchmark-Driven Formative Testing Study. JMIR Hum Factors. 2026 Feb 20;13:e71472. doi: 10.2196/71472. PMID 41719536