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| ID | Type | Description | Link |
|---|---|---|---|
| 13-DK-N096 | Other Identifier | NIDDK/NIH |
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Background:
- Sticking to a diet plan can be difficult, but is important for many different health reasons. Some people seem to have a harder time following and sticking to a diet plan than others. It is not clear whether people of different weights (lean or obese) might have differences in the way they adhere to diet plans. Researchers want to study three different groups of people based on their body mass index (BMI), which measures people based on their weight and height. The study will place the participants on a 6-week diet and see how well they follow the diet. The information from this study may help develop better weight-loss plans and healthy diet ideas.
Objectives:
Eligibility:
- Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI greater than 30).
Design:
Adherence, or "sticking to your diet" is important for successful initial weight loss and keeping off the weight over the long term (1). While early behavioral and dietary adherence have been associated with greater weight loss, sticking to a diet plan is difficult. It is not clear if adherence to any diet plan (even one which does not produce weight loss) is hard or whether people who are overweight have more difficulty with adhering to diet plans compared to people who are relatively lean.
The main aim of this study is to evaluate dietary adherence in 3 groups of individuals participating in a 6-week heart-healthy dietary intervention program. Two groups [1 (BMI < 25 kg/m(2)) and 2. Obese (BMI greater than or equal to 30 kg/m(2))] will receive a heart-healthy diet designed to maintain their weight, and the third group [3. Obese] will be given a heart-healthy diet that is 35% less than their daily calorie needs to lose weight. Participants will attend one counseling session per week and will be contacted randomly 1x/week by study staff for completion of a 24-hour dietary recall. They will complete daily food diaries and daily records using smart-phones. Prior to starting the assigned heart-healthy dietary intervention, participants will complete questionnaires that include questions about how motivated they are to follow a diet, lose weight, and change eating patterns. These findings may help us understand what factors affect adherence, and help us design weight loss studies that improve people's ability to stick to diet interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese underfeeding (UF) | Experimental | Obese randomized to received a 35% calorie reduced diet |
|
| Obese weight maintaining (WMEN) | Experimental | Randomized to receive a weight-maintaining diet |
|
| Lean weight maintaining (WMEN) | Experimental | Normal weight individuals receiving a weight-maintaining energy needs diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Underfeeding diet | Behavioral | Heart healthy diet with 35% reduced calories |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence Score | An adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: [1] Attendance (0-2), [2] Food diaries (0-3), [3] 24-hour food recall via interview (0-3), [4] computer survey (0-3), [5] 24-hour food recall via interview (0-3), [6] Ecological momentary assessment (0-6), and [7] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores. | Average over 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline to 6 Weeks | Weight loss from baseline, calculated as weight at 6 weeks - weight at baseline | 6 weeks |
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-INCLUSION CRITERIA:
BMI
Age greater than or equal to 18 years. Minors under the age of 18 will be excluded because growth and pubertal issues are significant parameters that could affect our outcomes and also because the time requirements of the study are such that they would interfere with school schedules. Participants must be healthy, as determined by medical history, physical examination, and laboratory tests.
Weight stable (plus or minus 2 percent) for last 3 months
EXCLUSION CRITERIA:
Candidates will be screened by phone to exclude those with BMI greater than or equal to 26 kg/m(2) and BMI less than or equal to 29 kg/m(2), significant health problems, including cancer, hypertension, diabetes, current and past 3-month use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (greater than 3 drinks/d). Women must not be pregnant or lactating, and be at least 1 year postpartum. Candidates with a history of psychotic disorder or hospitalization for psychiatric illness within the past 1 year will not be eligible. They will need to be weight stable for the past 3 months (plus or minus 2 percent) and cannot be in treatment for obesity or currently receiving psychotherapy. Individuals who meet criteria according to the phone screen will be invited to come to the unit for a screening visit and their screening sheets are placed in a locked filing cabinet. Forms from potential volunteers who are ineligible are shredded.
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| Name | Affiliation | Role |
|---|---|---|
| Marci Gluck, Ph.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIDDK, Phoenix | Phoenix | Arizona | 85014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18201869 | Background | Fappa E, Yannakoulia M, Pitsavos C, Skoumas I, Valourdou S, Stefanadis C. Lifestyle intervention in the management of metabolic syndrome: could we improve adherence issues? Nutrition. 2008 Mar;24(3):286-91. doi: 10.1016/j.nut.2007.11.008. Epub 2008 Jan 16. | |
| 18001195 | Background | Flegal KM, Graubard BI, Williamson DF, Gail MH. Weight-associated deaths in the United States. J Womens Health (Larchmt). 2007 Nov;16(9):1368-70. doi: 10.1089/jwh.2007.0547. No abstract available. |
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100 participants were assessed for eligibility, 30 were ineligible and 9 did not complete the run-in phase. Sixty-one were assigned to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obese Underfeeding (UF) | Obese randomized to received a 35% calorie reduced diet Underfeeding diet: Heart healthy diet with 35% reduced calories |
| FG001 | Obese Weight Maintaining (WMEN) | Randomized to receive a weight-maintaining diet Weight maintaining diet: Heart healthy weight-maintaining diet |
| FG002 | Lean Weight Maintaining (WMEN) | Normal weight individuals receiving a weight-maintaining energy needs diet Weight maintaining diet: Heart healthy weight-maintaining diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obese Underfeeding (UF) | Obese randomized to received a 35% calorie reduced diet Underfeeding diet: Heart healthy diet with 35% reduced calories |
| BG001 | Obese Weight Maintaining (WMEN) |
| 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 | Adherence Score | An adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: [1] Attendance (0-2), [2] Food diaries (0-3), [3] 24-hour food recall via interview (0-3), [4] computer survey (0-3), [5] 24-hour food recall via interview (0-3), [6] Ecological momentary assessment (0-6), and [7] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores. | Posted | Mean | Standard Deviation | score on a scale | Average over 6 weeks |
|
6 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 | Obese Underfeeding (UF) | Obese randomized to received a 35% calorie reduced diet Underfeeding diet: Heart healthy diet with 35% reduced calories |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marci E. Gluck | National Institute of Diabetes Digestive and Kidney Diseases/NIH | 602-200-5317 | gmarci@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2018 | Jul 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Weight maintaining diet | Behavioral | Heart healthy weight-maintaining diet |
|
|
| 9414332 | Background | Kassirer JP, Angell M. Losing weight--an ill-fated New Year's resolution. N Engl J Med. 1998 Jan 1;338(1):52-4. doi: 10.1056/NEJM199801013380109. No abstract available. |
| 32808484 | Derived | Stinson EJ, Piaggi P, Votruba SB, Venti C, Lovato-Morales B, Engel S, Krakoff J, Gluck ME. Is Dietary Nonadherence Unique to Obesity and Weight Loss? Results From a Randomized Clinical Trial. Obesity (Silver Spring). 2020 Nov;28(11):2020-2027. doi: 10.1002/oby.23008. |
Randomized to receive a weight-maintaining diet
Weight maintaining diet: Heart healthy weight-maintaining diet
| BG002 | Lean Weight Maintaining (WMEN) | Normal weight individuals receiving a weight-maintaining energy needs diet Weight maintaining diet: Heart healthy weight-maintaining diet |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight, kg | Mean | Standard Deviation | kg |
|
| Height, cm | Mean | Standard Deviation | cm |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Obese Weight Maintaining (WMEN) |
Randomized to receive a weight-maintaining diet Weight maintaining diet: Heart healthy weight-maintaining diet |
| OG002 | Lean Weight Maintaining (WMEN) | Normal weight individuals receiving a weight-maintaining energy needs diet Weight maintaining diet: Heart healthy weight-maintaining diet |
|
|
| Secondary | Change in Weight From Baseline to 6 Weeks | Weight loss from baseline, calculated as weight at 6 weeks - weight at baseline | Posted | Mean | Standard Deviation | kg | 6 weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Obese Weight Maintaining (WMEN) | Randomized to receive a weight-maintaining diet Weight maintaining diet: Heart healthy weight-maintaining diet | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Lean Weight Maintaining (WMEN) | Normal weight individuals receiving a weight-maintaining energy needs diet Weight maintaining diet: Heart healthy weight-maintaining diet | 0 | 23 | 0 | 23 | 0 | 23 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |