Obesity
Conditions
Brief summary
The purpose of this protocol is to define an individualized diet approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.
Interventions
BEHAVIORALStandard Lifestyle Intervention
Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the Mayo Clinic Diet program.
BEHAVIORALModified Lifestyle Intervention
Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the participants obesity phenotype.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults with obesity (BMI \>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina). * Age: 18-65 years. * Gender: Men or women.
Exclusion criteria
* Weight change greater than 3% in the previous 3 months (weight stable). * History of bariatric surgery including lap band and bariatric endoscopy. * Significant untreated psychiatric dysfunction including binge eating disorders and bulimia. * Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM * A positive score on the AUDIT-C questionnaire as judged by an investigator. * Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-week total body weight loss | 12 weeks | Change in body weight during the 12 week study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | 12 weeks | Change in waist circumference (cm) |
| Fat Loss | 12 weeks | Change in fat mass during the 12 week study using DEXA |
| Calorie Intake | 12 weeks | Change in daily calorie intake |
| Calories to Fullness | 12 weeks | Change in calories consumed to fullness during the 12 week study using satiation test |
| Gastric Emptying | 12 weeks | Change in half gastric emptying time during the 12 week study using scintigraphy |
| Responder Rate | 12 weeks | Proportion of patients losing \> 3% of total body weight |
| Anxiety Level | 12 weeks | Change is anxiety level during the 12 week study using the HADS-A scale |
| Emotional Eating | 12 weeks | Change is emotional eating level during the 12 week study using the TFEQ score |
| Resting Metabolic Rate | 12 weeks | Change in resting energy expenditure during the 12 week study using an indirect calorimetry |
| Adherence | 12 weeks | Adherence and compliance with program defined by the number of contacts with the team |
| Gastric Emptying 2 Hours | 12 weeks | Change in gastric emptying percentage at 2 hours during the 12 week study using scintigraphy |
Countries
United States
Outcome results
None listed