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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK097158-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| United States Air Force | FED |
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Purpose: This study aims to take the procedural and research-based lessons learned from a pilot weight loss intervention (IRB # 13-02563-XP), conducted by The University of Tennessee Health Science Center in 2013, and apply them to the current study of 204 active duty military personnel. The pilot study translated and tailored the Look Ahead weight loss intervention to an overweight/obese active duty U.S. Air Force population, while accommodating the lifestyle and environment that is unique to military members and evaluate materials and procedures used.
Rationale: Being overweight is now by far the leading medical reason for rejection in the military. Unfortunately, the impact of weight problems on the military does not stop with those turned away from military service. From 1998 to 2008, the Armed Forces Health Surveillance Center reported the percent of active military members who experienced medical encounters for overweight or obesity significantly increased. The estimated total days of work lost from absenteeism associated with active-duty personnel who are overweight or obese was 658,000. Using Department of Defense (DOD) estimates of average daily based, it was estimated that overweight and obesity costs the DOD $103 million dollars in health care costs annually. Note this estimate is for active duty personnel only. Furthermore, obesity is a major cause for the discharge of uniformed personnel.
The current study is inspired by the successful Look Ahead trial, a behavioral science obesity intervention treatment program that included: a collaborative approach, education, behavioral support, and motivational interviewing. The unique nature of this weight reduction study is significant. To our knowledge, there had not been a successful translation of a highly efficacious obesity treatment in the military until The University of Tennessee Health Science Center implemented a pilot version of the Fit Blue program for active duty U.S. Air Force members in 2013. Following a successful pilot and extant results from the Look Ahead trial, Investigators expect success during the full scale Fit Blue study.
This study is a weight loss intervention program tailored to a military population. Investigators will randomize 204 consented participants to either an intensive counselor-initiated weight loss intervention or a self-paced weight loss intervention. Neither of the aforementioned conditions are controls and both treatments are expected to result in weight reduction.
Procedures: This is a two-arm individually randomized trial. The Counselor-initiated group will follow a more intense counselor-initiated approach, where the counselor schedules weekly telephone sessions and contacts them directly. The Self-paced group uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor.
Potential participants will be recruited through the use of advertisements, electronic bulletins, emails, newspapers, and word-of-mouth. Prior to randomization, interested individuals will complete a phone screening, informed consent, two in-person data collection visits and obtain medical clearance, as well as participate in 1 week of dietary and physical activity self-monitoring.
The randomized participants will spend the next year involved in study interventions (either the Counselor-Initiated intervention or the Self-Paced intervention), diet and exercise self-monitoring, daily weighing, and may also include telephone counseling sessions.
The follow-up data collection visits will occur at 4 and 12 months after randomization. At these visits, physical measurements will be collected (i.e. height, weight, abdominal circumference, blood pressure and heart rate) and participants will complete various questionnaires. A Quality of Life questionnaire will also be administered by study personnel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counselor-Initiated | Experimental | Participants will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion. |
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| Self-Paced | Active Comparator | The Self-paced group uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone-based sessions (28 total) on a structured schedule | Behavioral | 28 sessions will be reviewed weekly and then bi-weekly with a trained motivational interviewing counselor for those individuals randomly assigned to the counselor-initiated condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Loss (Baseline to 12 Months) | The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will be using the baseline weight as a covariate in the final primary model where the two arms will be compared in terms of the percentage of weight loss. | 12 month intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The Relationship Between Attendance and Percent Weight Loss | Evaluating the impact of intervention session attendance on percent weight loss outcome, as a measure of adherence. | 12 month intervention |
| The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Krukowski, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Ambulatory Surgical Center/Lackland Air Force Base | San Antonio | Texas | 78236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34259635 | Derived | Farage G, Simmons C, Kocak M, Klesges RC, Talcott GW, Richey P, Hare M, Johnson KC, Sen S, Krukowski R. Assessing the Contribution of Self-Monitoring Through a Commercial Weight Loss App: Mediation and Predictive Modeling Study. JMIR Mhealth Uhealth. 2021 Jul 14;9(7):e18741. doi: 10.2196/18741. | |
| 33949954 | Derived | Fahey MC, Klesges RC, Kocak M, Gladney LA, Talcott GW, Krukowski RA. Counselor Efficiency at Providing Feedback in a Technology-Based Behavioral Weight Loss Intervention: Longitudinal Analysis. JMIR Form Res. 2021 May 5;5(5):e23974. doi: 10.2196/23974. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Counselor-Initiated | Will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 4, 2017 |
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| Phone-based sessions upon request | Behavioral | For those individuals randomly assigned to the self-paced condition, the 28 sessions are still available to them, the participant has to call to initiate sessions. |
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| Weight self-monitoring | Behavioral | Each randomized participant will be given a Body Trace scale that will electronically record their weight. |
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| Dietary and physical activity self-monitoring | Behavioral | Each randomized participant will be given a free account to Lose It! Premium, an online food/activity diary for self-monitoring. |
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| Scheduled tailored interventionist feedback | Behavioral | Randomly assigned participants to the counselor-initiated condition will receive feedback on their progress throughout their sessions with their assigned interventionist. |
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| Dietary goals | Behavioral | Each randomized participant will receive a daily calorie goal range based on their current weight, gender, and BMI. |
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| Meal replacements | Behavioral | Randomized participants will receive coupons for meal replacements including oatmeal and popcorn. |
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| Physical activity goals | Behavioral | Each participant will complete the Global Physical Activity Questionnaire which will determine their weekly exercise goals. |
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| Toolbox | Behavioral | The toolbox includes additional treatment options for those who wish to take advantage of them. Items may include: food scales, cookbooks, etc. These items may be checked out and must be returned prior to the completion of the study. |
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| Challenges | Behavioral | There will be several challenges designed to increase participant interest and provide a specific goal (e.g., increase self-monitoring). Participants who successfully completed the challenges will be given a small award. |
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| Tailored interventionist feedback upon request | Behavioral | Randomly assigned participants to the self-paced condition have the option to receive feedback on their progress upon request. |
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We will evaluate the impact of dietary and physical activity self-monitoring adherence (using Lose It website/app) on weight loss outcome. |
| 12 month intervention |
| The Relationship Between Self-weighing on Weight Loss | We will also evaluated the impact of self-weighing (using Body Trace e-scales) on weight loss outcomes. | 12 month intervention |
| 31773873 | Derived | Manz KC, Waters TM, Clifton HE, Kocak M, Klesges RC, Talcott GW, Krukowski RA. Cost-Effectiveness of a Weight Loss Intervention: An Adaptation of the Look AHEAD Lifestyle Intervention in the US Military. Obesity (Silver Spring). 2020 Jan;28(1):89-96. doi: 10.1002/oby.22681. Epub 2019 Nov 26. |
| 31168928 | Derived | Pebley K, Klesges RC, Talcott GW, Kocak M, Krukowski RA. Measurement Equivalence of E-Scale and In-Person Clinic Weights. Obesity (Silver Spring). 2019 Jul;27(7):1107-1114. doi: 10.1002/oby.22512. Epub 2019 Jun 5. |
| 30277031 | Derived | Fahey MC, Klesges RC, Kocak M, Wayne Talcott G, Krukowski RA. Changes in the Perceptions of Self-weighing Across Time in a Behavioral Weight Loss Intervention. Obesity (Silver Spring). 2018 Oct;26(10):1566-1575. doi: 10.1002/oby.22275. |
| 30277030 | Derived | Krukowski RA, Hare ME, Talcott GW, Gladney LA, Johnson KC, Richey PA, Kocak M, Keller PL, Hryshko-Mullen A, Klesges RC. Dissemination of the Look AHEAD Intensive Lifestyle Intervention in the United States Military: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Oct;26(10):1558-1565. doi: 10.1002/oby.22293. |
| 30125001 | Derived | Fahey MC, Hare ME, Talcott GW, Kocak M, Hryshko-Mullen A, Klesges RC, Krukowski RA. Characteristics Associated With Participation in a Behavioral Weight Loss Randomized Control Trial in the U.S. Military. Mil Med. 2019 Mar 1;184(3-4):e120-e126. doi: 10.1093/milmed/usy199. |
| 25545025 | Derived | Krukowski RA, Hare ME, Talcott GW, Johnson KC, Richey PA, Kocak M, Balderas J, Colvin L, Keller PL, Waters TM, Klesges RC. Dissemination of the Look AHEAD intensive lifestyle intervention in the United States Air Force: study rationale, design and methods. Contemp Clin Trials. 2015 Jan;40:232-9. doi: 10.1016/j.cct.2014.12.014. Epub 2014 Dec 26. |
| FG001 | Self-Paced | Uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Counselor-Initiated | Will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion. Phone-based sessions (28 total) on a struct |
| BG001 | Self-Paced | Uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Measured weight on a calibrated scale | Mean | Standard Deviation | kg |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Weight Loss (Baseline to 12 Months) | The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will be using the baseline weight as a covariate in the final primary model where the two arms will be compared in terms of the percentage of weight loss. | Posted | Mean | Standard Deviation | percent weight loss | 12 month intervention |
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| Secondary | The Relationship Between Attendance and Percent Weight Loss | Evaluating the impact of intervention session attendance on percent weight loss outcome, as a measure of adherence. | Posted | Number | spearman rho correlation | 12 month intervention |
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| Secondary | The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss | We will evaluate the impact of dietary and physical activity self-monitoring adherence (using Lose It website/app) on weight loss outcome. | Posted | Number | Spearman's rho correlation | 12 month intervention |
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| Secondary | The Relationship Between Self-weighing on Weight Loss | We will also evaluated the impact of self-weighing (using Body Trace e-scales) on weight loss outcomes. | Posted | Number | spearman's rho correlation | 12 month intervention |
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13 months
Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
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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 | Counselor-Initiated | Participants will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion. | 0 | 124 | 5 | 124 | 75 | 124 |
| EG001 | Self-Paced | The Self-paced group uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. | 0 | 124 | 5 | 124 | 55 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Gastric Carcinoid Tumor | Gastrointestinal disorders | Systematic Assessment |
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| Third degree burns | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Total knee replacement | Surgical and medical procedures | Systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
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| Kidney problems secondary to antibiotics and dehydration while being treated for an ear infection | Renal and urinary disorders | Systematic Assessment |
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| Tubal ligation | Surgical and medical procedures | Systematic Assessment |
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| New diagnosis of prostate cancer with prostatectomy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Syncope | Cardiac disorders | Systematic Assessment | After running, investigation did not find a cause |
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| Tibial osteotomy and osteochondral allograft transfer | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Common cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Foot injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Wrist injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Krukowski | University of Tennessee Health Science Center | 9014482426 | rkrukows@uthsc.edu |
| Nov 27, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Caucasian |
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| Other |
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