Obese, Overweight
Conditions
Brief summary
This study will test the effectiveness of two distinct treatments for weight loss: 1. Motivational Interviewing 2. Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.
Interventions
BEHAVIORALMotivational Interviewing
5 sessions of motivational interviewing over a period of 3 months.
BEHAVIORALNutritional Counseling
5 sessions of nutritional counseling over a period of 3 months.
BEHAVIORALTreatment as usual with primary care physician
Participants will be encouraged to continue their care with their primary care physician.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI 25-55 * Daily access to internet and phone
Exclusion criteria
* Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders) * Meets criteria for current substance abuse or dependence * Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating * Pregnant, breastfeeding, or plans to become pregnant during the treatment period * Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack * Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function) * Uncontrolled diabetes, thyroid conditions, or hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight in Pounds. | 1.5 months after treatment start (Baseline) | Body weight lost in pounds measured 1.5 months after first treatment session. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months. | 30 |
| Nutritional Counseling Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months. | 29 |
| Treatment as Usual Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician. | 30 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Motivational Interviewing | Nutritional Counseling | Treatment as Usual | Total |
|---|---|---|---|---|
| Age, Continuous | 47.07 years STANDARD_DEVIATION 9.97 | 48.93 years STANDARD_DEVIATION 11.59 | 47.77 years STANDARD_DEVIATION 10.05 | 47.9 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 3 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 22 Participants | 21 Participants | 62 Participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 24 Participants | 68 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 6 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 | 0 / 30 |
Outcome results
Primary
Body Weight in Pounds.
Body weight lost in pounds measured 1.5 months after first treatment session.
Time frame: 1.5 months after treatment start (Baseline)
Population: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing | Body Weight in Pounds. | -3.1 pounds | Standard Deviation 4.6 |
| Nutritional Counseling | Body Weight in Pounds. | -3.4 pounds | Standard Deviation 5.2 |
| Treatment as Usual | Body Weight in Pounds. | 0.1 pounds | Standard Deviation 3.5 |
Primary
Body Weight in Pounds.
Body weight lost in pounds measured 3 months after first treatment session.
Time frame: 3 months after treatment start (Baseline)
Population: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing | Body Weight in Pounds. | -3.3 pounds | Standard Deviation 6.5 |
| Nutritional Counseling | Body Weight in Pounds. | -4.9 pounds | Standard Deviation 6.1 |
| Treatment as Usual | Body Weight in Pounds. | -0.4 pounds | Standard Deviation 6.2 |
Primary
Body Weight in Pounds.
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).
Time frame: 6 months after treatment start (Baseline)
Population: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing | Body Weight in Pounds. | -2.6 pounds | Standard Deviation 8.7 |
| Nutritional Counseling | Body Weight in Pounds. | -5.7 pounds | Standard Deviation 9 |
| Treatment as Usual | Body Weight in Pounds. | 0.4 pounds | Standard Deviation 7.2 |