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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK092279-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will test the effectiveness of two distinct treatments for weight loss:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental |
| |
| Nutritional Counseling | Active Comparator |
| |
| Treatment as usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | 5 sessions of motivational interviewing over a period of 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight in Pounds. | Body weight lost in pounds measured 1.5 months after first treatment session. | 1.5 months after treatment start (Baseline) |
| Body Weight in Pounds. | Body weight lost in pounds measured 3 months after first treatment session. | 3 months after treatment start (Baseline) |
| Body Weight in Pounds. | Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends). | 6 months after treatment start (Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Barnes, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25298016 | Result | Barnes RD, White MA, Martino S, Grilo CM. A randomized controlled trial comparing scalable weight loss treatments in primary care. Obesity (Silver Spring). 2014 Dec;22(12):2508-16. doi: 10.1002/oby.20889. Epub 2014 Oct 9. | |
| 31816053 | Derived | Wiedemann AA, Baumgardt SS, Ivezaj V, Kerrigan SG, Lydecker JA, Grilo CM, Barnes RD. Getting a head start: identifying pretreatment correlates associated with early weight loss for individuals participating in weight loss treatment. Transl Behav Med. 2021 Feb 11;11(1):236-243. doi: 10.1093/tbm/ibz149. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing | Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months. |
| FG001 | Nutritional Counseling | Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months. |
| FG002 | Treatment as Usual | Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Chi-square for categorical variables and ANOVAs for continuous variables.
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing | Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months. |
| BG001 | Nutritional Counseling | Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight in Pounds. | Body weight lost in pounds measured 1.5 months after first treatment session. | 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. | Posted | Mean | Standard Deviation | pounds | 1.5 months after treatment start (Baseline) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interviewing | Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months. |
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Treatment as Usual (TAU) was subsequently referred to as Usual Care (UC) when the study results were disseminated because the literature evolved regarding treatment terms. UC more accurately reflect the condition.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Barnes | Yale Medical School | 2037856395 | rachel.barnes@yale.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D015596 | Nutrition Assessment |
| D013812 | Therapeutics |
| D058007 | Physicians, Primary Care |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Nutritional Counseling | Behavioral | 5 sessions of nutritional counseling over a period of 3 months. |
|
| Treatment as usual with primary care physician | Behavioral | Participants will be encouraged to continue their care with their primary care physician. |
|
| BG002 | Treatment as Usual | Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Treatment as Usual | Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician. |
|
|
| Primary | Body Weight in Pounds. | Body weight lost in pounds measured 3 months after first treatment session. | 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. | Posted | Mean | Standard Deviation | pounds | 3 months after treatment start (Baseline) |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | pounds | 6 months after treatment start (Baseline) |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Nutritional Counseling | Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months. | 0 | 29 | 0 | 30 |
| EG002 | Treatment as Usual | Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician. | 0 | 30 | 0 | 30 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D010820 | Physicians |
| D006282 | Health Personnel |