Weight Gain, Obesity
Conditions
Keywords
weight gain, weight loss
Brief summary
The GEM intervention leverages the patient-centered medical home model by using the GEM tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.
Detailed description
To establish the efficacy of the GEM intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with Medical Home models of care to compare the GEM intervention (intervention arm) with Enhanced Usual Care (educational materials; control arm). The specific aims of this study are: * Test the impact of the GEM intervention on weight change, and clinical and behavioral outcomes. * Identify predictors of weight loss in the GEM intervention arm related to: a) goal-setting processes and b) intervention components * Determine the impact of the GEM intervention on obesity-related counseling practices and attitudes in primary care providers.
Interventions
BEHAVIORALGEM
Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
BEHAVIORALEnhanced Usual Care
Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 18-69 years of age, * Body mass index of ≥30kg/m2 OR * Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity * Hypertension * High Cholesterol * Sleep Apnea * Osteoarthritis * Metabolic Syndrome * Prediabetes * Under primary care team care with at least one prior visit with their provider in the past 24 months * Access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months
Exclusion criteria
* Patients who do not speak English or Spanish, * Have active psychosis or other cognitive issues, * Psychoactive substance use * Diabetes * Taking prescription weight-loss medication * Health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis * Participated in MOVE!, DPP, or another intensive weight management program (\>3 sessions) in the past year, * Have a history of bariatric surgery, * Are pregnant, or become pregnant during the intervention period, * Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment, * Have a provider who states they should not participate, * Patients who do not want to lose weight * Have self-reported inability to read at 5th grade level.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Weight From Baseline | Baseline, Month 12 |
| Change in Waist Circumference From Baseline | Baseline, Month 12 |
| Change in Systolic Blood Pressure (SBP) From Baseline | Baseline, Month 12 |
| Change in Diastolic Blood Pressure (DBP) From Baseline | Baseline, Month 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Obesity + GEM Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months. | 220 |
| Participants With Obesity + Enhanced Usual Care Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed. | 269 |
| Total | 489 |
Baseline characteristics
| Characteristic | Participants With Obesity + GEM | Total | Participants With Obesity + Enhanced Usual Care |
|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 12.1 | 49.8 years STANDARD_DEVIATION 12.1 | 50.2 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 99 Participants | 199 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 282 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 96 Participants | 238 Participants | 142 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 16 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 80 Participants | 152 Participants | 72 Participants |
| Race (NIH/OMB) White | 35 Participants | 76 Participants | 41 Participants |
| Region of Enrollment United States | 220 participants | 489 participants | 269 participants |
| Sex: Female, Male Female | 116 Participants | 273 Participants | 157 Participants |
| Sex: Female, Male Male | 104 Participants | 216 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 220 | 3 / 269 |
| other Total, other adverse events | 36 / 220 | 43 / 269 |
| serious Total, serious adverse events | 53 / 220 | 81 / 269 |
Outcome results
Primary
Change in Diastolic Blood Pressure (DBP) From Baseline
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Obesity + GEM | Change in Diastolic Blood Pressure (DBP) From Baseline | 1.6 mmHg | Standard Deviation 1.4 |
| Participants With Obesity + Enhanced Usual Care | Change in Diastolic Blood Pressure (DBP) From Baseline | 3.2 mmHg | Standard Deviation 1.5 |
Primary
Change in Systolic Blood Pressure (SBP) From Baseline
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Obesity + GEM | Change in Systolic Blood Pressure (SBP) From Baseline | 1.8 mmHg | Standard Deviation 1.7 |
| Participants With Obesity + Enhanced Usual Care | Change in Systolic Blood Pressure (SBP) From Baseline | 3.2 mmHg | Standard Deviation 1.7 |
Primary
Change in Waist Circumference From Baseline
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Obesity + GEM | Change in Waist Circumference From Baseline | -1.3 centimeters | Standard Deviation 0.5 |
| Participants With Obesity + Enhanced Usual Care | Change in Waist Circumference From Baseline | -0.6 centimeters | Standard Deviation 0.6 |
Primary
Change in Weight From Baseline
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Obesity + GEM | Change in Weight From Baseline | -1.4 kilograms | Standard Deviation 0.8 |
| Participants With Obesity + Enhanced Usual Care | Change in Weight From Baseline | -0.8 kilograms | Standard Deviation 0.9 |