Obesity, Diabetes, Hypertension, Hyperlipidemia
Conditions
Keywords
glucose, insulin, lipids, C-reactive protein, adiponectin, leptin, TNF alpha, IL-6, Quality of Life, functional status
Brief summary
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.
Interventions
BEHAVIORALExercise
Participants will participate in supervised exercise sessions
BEHAVIORALReduced Calorie Diet
Participants will follow a reduced calorie diet
BEHAVIORALWeight Maintenance Diet
Participants will follow a weight maintenance diet
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 65 years of age * BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)
Exclusion criteria
* difficulties chewing or swallowing food * digestive diseases that may affect the ability to follow a high fiber diet * cognitive impairment * depression * recent weight change (+/- 10 lbs in the last 12 months) * poorly controlled blood pressure * history of non-skin cancer in last 5 years * cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure * major liver dysfunction * current smoker or quit less than months prior * history of prior surgical procedures for weight control or liposuction * use of estrogen or testosterone replacement therapy * current use of insulin or sulfonylurea agents * current use of corticosteroids \> 5 days/month on average * current use of medications for treatment of psychosis or manic-depressive illness * use of weight-loss medications in previous 3 months * dependence on others for food procurement or preparation * ischemic changes on exercise treadmill test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Abdominal Fat Mass | Baseline to 1 year | Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiometabolic Risk Factors | Baseline to 1 year | We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year |
| Weight Change/Maintenance | Baseline to 1 year | The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year |
Countries
United States
Participant flow
Pre-assignment details
3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| Control Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions | 54 |
| 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 | 55 |
| Total | 164 |
Baseline characteristics
| Characteristic | Weight Loss | Total | Weight Maintenance | Control |
|---|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 4.8 | 70.3 years STANDARD_DEVIATION 4.7 | 70.5 years STANDARD_DEVIATION 4.8 | 69.9 years STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 39 Participants | 12 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 124 Participants | 43 Participants | 39 Participants |
| Region of Enrollment United States | 55 participants | 164 participants | 55 participants | 54 participants |
| Sex: Female, Male Female | 32 Participants | 102 Participants | 33 Participants | 37 Participants |
| Sex: Female, Male Male | 23 Participants | 62 Participants | 22 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 55 | 36 / 54 | 40 / 55 |
| serious Total, serious adverse events | 8 / 55 | 11 / 54 | 12 / 55 |
Outcome results
Primary
Change in Abdominal Fat Mass
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Time frame: Baseline to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Loss | Change in Abdominal Fat Mass | -192.6 Cubic cm | Standard Deviation 185.2 |
| Control | Change in Abdominal Fat Mass | -21.9 Cubic cm | Standard Deviation 173.7 |
| Weight Maintenance | Change in Abdominal Fat Mass | -275 Cubic cm | Standard Deviation 189.2 |
Secondary
Cardiometabolic Risk Factors
We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year
Time frame: Baseline to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Loss | Cardiometabolic Risk Factors | -7.2 mg/dL | Standard Deviation 2.8 |
| Control | Cardiometabolic Risk Factors | 1.2 mg/dL | Standard Deviation 2.5 |
| Weight Maintenance | Cardiometabolic Risk Factors | -1.2 mg/dL | Standard Deviation 2.5 |
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
Time frame: Baseline to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Loss | Weight Change/Maintenance | -3.9 Kg | Standard Deviation 0.7 |
| Control | Weight Change/Maintenance | -1.3 Kg | Standard Deviation 0.7 |
| Weight Maintenance | Weight Change/Maintenance | -0.9 Kg | Standard Deviation 0.7 |