Treatment of overweight and mild obesity Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Overweight and mildly obese adults (BMI between 25.00 to 34.99 kg/m²)
Exclusion criteria
Exclusion criteria: 1. Any metabolic or endocrine related dysregulation including but not limited to: diagnosis of type I or type II diabetes, liver, kidney, or pancreatic dysfunction 2. History of sleep-affecting disorders 3. Recent highly stressful events within 4 weeks of baseline 4. Usage of weight-influencing medications within 1 month of baseline 5. Use of Ca channel blockers, anxiolytics or SSRIs, no more than 5 times per month, and not within seven days of baseline 6. Unstable use of other medication 7. Current hormone therapy 8. Excessive alcohol consumption 9. Smoking 10. Elevated caffeine intake 11. Irregular sleep-inducing work schedules 12. Inability to engage in spontaneous physical activity 13. Metabolic disorder, a sleep disorder, or a psychiatric condition 14. Pregnancy, attempts at conception, or breastfeeding 15. Use of sleep/weight supplements or medications 16. Actively intermittent fasting, are actively trying to lose weight, or have lost more than ± 3kg in previous 3 months 17. Individuals deemed incompatible with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight (kg) measured using a smart scale (BodyTrace, Inc.), at Baseline, Day 30 and Day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Food cravings measured using the Food Cravings Questionnaire (Meule et al., 2014) at Baseline, Day 30 and Day 60. 2. Health-related quality of life measured using the CDC Health-related Quality of Life Core Healthy Days at Baseline, Day 30 and Day 60. 3. Mood measured using Profile of Mood States (POMS) Questionnaire (McNair et al., 1992) at Baseline, Day 30, and Day 60. 4. Anxiety measured using the Trait Anxiety Inventory (Spielberger et al., 1983) at Baseline, Day 30, and Day 60. 5. Perceived stress measured using the Perceived Stress Scale-4 (Cohen et al., 1983) at Baseline, Day 30, and Day 60. | — |
Countries
United States of America