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The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss | Experimental | Participants receive Exercise and Reduced Calorie Diet Interventions |
|
| Control | Active Comparator | Participants receive Exercise Intervention |
|
| Weight Maintenance | Active Comparator | Participants receive Exercise and a Weight Maintenance Diet Interventions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Participants will participate in supervised exercise sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Fat Mass | Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiometabolic Risk Factors | We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year | Baseline to 1 year |
| Weight Change/Maintenance | The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamy D Ard, MD | University of Alabama at Birmingham | Principal Investigator |
| Julie Locher, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41832848 | Derived | DiNatale JC, Ellis AC, Ard JD, Locher JL, Crowe-White KM. The Visceral Adiposity Index (VAI) as a predictor for metabolic syndrome in a sample of older adults with obesity. Nutrition. 2026 Jul;147:113158. doi: 10.1016/j.nut.2026.113158. Epub 2026 Feb 10. | |
| 35654771 | Derived | Senkus KE, Crowe-White KM, Bolland AC, Locher JL, Ard JD. Changes in adiponectin:leptin ratio among older adults with obesity following a 12-month exercise and diet intervention. Nutr Diabetes. 2022 Jun 2;12(1):30. doi: 10.1038/s41387-022-00207-1. |
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3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Weight Loss | Participants receive Exercise Only and Reduced Calorie Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Reduced Calorie Diet: Participants will follow a reduced calorie diet |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Reduced Calorie Diet | Behavioral | Participants will follow a reduced calorie diet |
|
| Weight Maintenance Diet | Behavioral | Participants will follow a weight maintenance diet |
|
| Baseline to 1 year |
| 35471192 | Derived | Senkus KE, Crowe-White KM, Locher JL, Ard JD. Relative fat mass assessment estimates changes in adiposity among female older adults with obesity after a 12-month exercise and diet intervention. Ann Med. 2022 Dec;54(1):1160-1166. doi: 10.1080/07853890.2022.2067352. |
| 34486528 | Derived | Bragg AE, Crowe-White KM, Ellis AC, Studer M, Phillips F, Samsel S, Parton J, Locher JL, Ard JD. Changes in Cardiometabolic Risk Among Older Adults with Obesity: An Ancillary Analysis of a Randomized Controlled Trial Investigating Exercise Plus Weight Maintenance and Exercise Plus Intentional Weight Loss by Caloric Restriction. J Acad Nutr Diet. 2022 Feb;122(2):354-362. doi: 10.1016/j.jand.2021.07.009. Epub 2021 Sep 1. |
| 31145045 | Derived | Crowe-White KM, Ellis AC, Mehta T, Locher JL, Ard JD. Dietary Quality Assessed by the HEI-2010 and Biomarkers of Cardiometabolic Disease: An Exploratory Analysis. J Am Coll Nutr. 2019 Sep-Oct;38(7):640-647. doi: 10.1080/07315724.2019.1580168. Epub 2019 May 30. |
Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions |
| FG002 | Weight Maintenance | Participants receive Exercise Only and a Weight Maintenance Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Weight Maintenance Diet: Participants will follow a weight maintenance diet |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Weight Loss | Participants receive Exercise Only and Reduced Calorie Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Reduced Calorie Diet: Participants will follow a reduced calorie diet |
| BG001 | Control | Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions |
| BG002 | Weight Maintenance | Participants receive Exercise Only and a Weight Maintenance Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Weight Maintenance Diet: Participants will follow a weight maintenance diet |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change in Abdominal Fat Mass | Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year | Posted | Mean | Standard Deviation | Cubic cm | Baseline to 1 year |
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| Secondary | Cardiometabolic Risk Factors | We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year | Posted | Mean | Standard Deviation | mg/dL | Baseline to 1 year |
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| |||||||||||||||||||||||||||||||||
| Secondary | Weight Change/Maintenance | The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year | Posted | Mean | Standard Deviation | Kg | Baseline to 1 year |
|
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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 | Weight Loss | Participants receive Exercise Only and Reduced Calorie Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Reduced Calorie Diet: Participants will follow a reduced calorie diet | 8 | 55 | 36 | 55 | ||
| EG001 | Control | Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions | 11 | 54 | 36 | 54 | ||
| EG002 | Weight Maintenance | Participants receive Exercise Only and a Weight Maintenance Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Weight Maintenance Diet: Participants will follow a weight maintenance diet | 12 | 55 | 40 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Urinary symptoms | Renal and urinary disorders | Systematic Assessment |
| ||
| Heart rate and blood pressure abnormalities | Cardiac disorders | Systematic Assessment |
| ||
| Complications related to surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Pain | Nervous system disorders | Systematic Assessment |
| ||
| Broken bone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| General, Constitutional | General disorders | Systematic Assessment |
| ||
| Genitourinary | Renal and urinary disorders | Systematic Assessment |
| ||
| Muscle and bone issues | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nervous system | Nervous system disorders | Systematic Assessment |
| ||
| Psychiatric and mood changes | Psychiatric disorders | Systematic Assessment |
|
This trial was completed in older adults (age 65+) with at least one major risk factor for heart disease.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamy Ard, MD | Wake Forest School of Medicine | 3367169837 | jard@wakehealth.edu |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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