N/A
Completed N=624
Adaptive Goals and Interventions for Lifestyle Enhancement
Source: ClinicalTrials.gov NCT04922216 ↗Enrolled (actual)
624
Serious AEs
1.4%
Results posted
Jul 2025
Primary outcomePrimary: Weight (kg) — -3.61; -3.31; -3.32; -3.60 kg — p=0.52
Summary
Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools "just in time". This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight (kg) |
-2.54; -2.30; -2.22; -2.63; -2.69; -2.16 | 0.43 |
| SECONDARY Weight (kg) |
-2.54; -2.30; -2.22; -2.63; -2.69; -2.16 | 0.43 |
| SECONDARY Percent of Participants Reaching >/= 5% Weight Loss |
100; 101; 89; 112; 107; 94 | 0.95 |
| SECONDARY Diet |
-378.6; -485.3; -470.3; -391.9; -452.3; -411.6 | — |
| SECONDARY Physical Activity |
180.4; 322.6; 252.1; 250.8; 309.3; 192.9 | — |
| SECONDARY Sedentary Behavior Score |
-35.3; -36.1; -33.9; -37.6; -41.1; -30.3 | — |
| SECONDARY Autonomy Support Score |
5.14; 5.11; 5.08; 5.17; 5.16; 5.09 | — |
| SECONDARY Competence for Diet and Physical Activity Scores |
0.88; 0.74; 0.41; 1.23; 0.78; 0.84 | — |
| SECONDARY Perceived Message Relevance Score |
3.34; 3.37; 3.29; 3.42; 3.35; 3.36 | — |
| SECONDARY Treatment Self-Regulation Score |
-0.19; -0.23; -0.16; -0.25; -0.19; -0.22 | — |
| SECONDARY Relatedness Score |
4.91; 4.95; 4.86; 5.01; 4.99; 4.88 | — |
| SECONDARY Diet Self-monitoring Adherence |
73.3; 67.9; 69.3; 71.9; 69.2; 72.1 | — |
| SECONDARY Weighing Adherence |
90.2; 87.4; 87.5; 90.0; 87.9; 89.6 | — |
| SECONDARY Physical Activity Self-monitoring Adherence |
134.1; 133.4; 133.2; 134.3; 132.7; 134.8 | — |
Eligibility Criteria
Inclusion Criteria
- body mass index (BMI) of 25-45 kg/m^2
- English-speaking and writing
- own a smartphone with a data and text messaging plan
- willing to be randomized to any levels of the factors
Exclusion Criteria
- 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 cancer treatment within the past 5 years or tuberculosis
- 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)
- Lost 10 or more pounds (and kept it off) in the last 6 months
- Currently taking weight loss medications
- Report a past diagnosis of or current treatment for a DSM-V (Diagnostic and Statistical Manual 5) eating disorder (anorexia nervosa or bulimia nervosa)
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- History of psychotic disorder or bipolar disorder
- Another member of the household is a participant or staff member on this trial
- Currently participating in a weight loss, nutrition or physical activity study or program or other study that would interfere with this study
Data sourced from ClinicalTrials.gov (NCT04922216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.