Lifestyle, Obesity, Overweight, Prediabetes, Weight Loss
Conditions
Keywords
Obesity, Overweight, Prediabetes, Smartphone application, Technology, Weight Loss, Lifestyle Intervention
Brief summary
The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.
Interventions
DEVICEWearable technology, smartscale
BEHAVIORALSmartphone applications
BEHAVIORALStandard Weight Management Visits
Sponsors
The Obesity Treatment Foundation
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Overweight or obese BMI 25-42 kg/m2 * Employed in sedentary occupations * Own a personal smartphone with unlimited data plan or \>4 GigaByte data * Proficient with use of smartphone applications and technology with current daily usage * Ability to engage in moderate intensity exercise * Weight stability for the last 2 months * Participants must be willing to comply with all study-related procedures
Exclusion criteria
* Current or planned pregnancy * Cardiovascular, pulmonary, renal disease, joint disease * Uncontrolled thyroid disease * History of eating disorders, psychiatric disease * History of substance abuse or dependence in the last 1 year * Diabetes * Shift work * Previous weight loss surgery * Use of weight loss drugs/diet/program in the last 6 weeks * Inability to increase walking as a form of exercise and to engage in moderate intensity exercise * Other conditions or medications that affect body weight/appetite/metabolism * Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation * Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight in kg | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline waist circumference | 6 months | — |
| Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) | 6 months | — |
| Change from baseline hemoglobin A1c | 6 months | — |
| Change from baseline plasma triglycerides | 6 months | — |
| Change from baseline blood pressure | 6 months | — |
| Change in Quality of Life | 6 months after receiving the intervention | SF36 Questionnaire in wait-listed control group after the intervention |
| Change in insulin resistance by homeostasis model assessment (HOMA-IR) | 12 months compared to baseline and 6 months after receiving the intervention | Wait-listed control group |
| Change in hemoglobin A1c | 12 months compared to baseline and 6 months after receiving the intervention and from baseline | Wait-listed control group |
| Change in plasma triglycerides | 12 months compared to baseline and 6 months after receiving the intervention | Wait-listed control group |
| Change from baseline body weight in kg | 3 months | — |
Countries
United States
Outcome results
None listed