Obesity, Overweight
Conditions
Brief summary
Motivational interviewing and nutritional counseling for weight loss in primary care.
Detailed description
Overweight and obese participants will be recruited through local primary care offices. This study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. The treatment will be supplemented by internet support.
Interventions
BEHAVIORALmotivational interviewing and nutrition
Motivational Interviewing and Nutritional Counseling
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI 25-55 * Daily access to internet and phone * Recruited through local primary care offices. * Age 18-65
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/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 | 3 months | Body weight in pounds measured 3 months after starting treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight in Pounds | 6 months | Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing and Nutrition Motivational interviewing and nutritional counseling.
motivational interviewing and nutrition: Motivational Interviewing and Nutritional Counseling | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Motivational Interviewing and Nutrition |
|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 10.6 |
| Baseline Weight | 212.2 pounds STANDARD_DEVIATION 34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Body Weight in Pounds
Body weight in pounds measured 3 months after starting treatment.
Time frame: 3 months
Population: 27 participants completed treatment, 28 participants completed the post treatment assessment (i.e., one participant who dropped from treatment completed the post treatment assessment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing and Nutrition | Body Weight in Pounds | 207.4 pounds | Standard Deviation 32.7 |
Secondary
Body Weight in Pounds
Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing and Nutrition | Body Weight in Pounds | 204.8 pounds | Standard Deviation 34.6 |