N/A
N=452
Phone Coaching and Internet-delivered Weight Loss
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03867981 ↗Enrolled (actual)
452
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Percent Weight Change at 4 Months — -6.2; -7.0; -4.5 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet-based weight loss program (Behavioral); Brief phone coaching (Behavioral); Extended phone coaching (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Miriam Hospital
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Weight Change at 4 Months |
-6.2; -7.0; -4.5 | — |
| PRIMARY Percent Weight Change at 12 Months |
-4.9; -5.5; -3.9 | — |
| SECONDARY Cost of Supplemental Coaching Per kg of Weight Loss |
13.2; 30.8 | — |
| SECONDARY Change in Physical Activity Minutes (Min/wk) |
55.37; 44.45; 24.01 | — |
| SECONDARY Change in Dietary Intake (Kcals) |
-417.78; -528.51; -500.51 | — |
| SECONDARY Self-monitoring of Calorie Intake |
79.5; 85.4; 66.5 | — |
| SECONDARY Video Lesson Viewing |
68.7; 83.0; 52.0 | — |
Summary
The purpose of this study is to examine whether adding phone coaching to an Internet-based weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals will receive a 4-month, Internet-delivered weight loss program followed by an 8-month Internet-delivered weight loss maintenance program. Some individuals will also be selected to receive either 3 weeks or 12 weeks of phone coaching. Assessments of weight, diet, physical activity, and psychosocial factors will occur at baseline, 4 months, and 1 year.
Eligibility Criteria
Inclusion Criteria
- Age 18-70
- BMI: 25-45 kg/m2
- Regular internet access
Exclusion Criteria
- Currently pregnant, <6 months post-partum, nursing, or planning to become pregnant within the next 12 months.
- Current enrollment in a commercial weight loss program or other weight loss research study
- Currently taking weight loss medications
- Previously had bariatric surgery
- Inability to walk 2 blocks without stopping
- Any medical condition for which weight loss, dietary restriction, or physical activity is contraindicated
Data sourced from ClinicalTrials.gov (NCT03867981). 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.