The first phase of the study is a feasibility survey of eligible participants, completed prior to initiating the intervention. The intervention consists of a 6-month 1:1 randomized trial with a waitlist control that recruits 120 older AA women. The rationale for these aims is that the successful completion is expected to provide evidence that a community-based, peer-led weight loss program with a national infrastructure can help a vulnerable, underserved population lose weight and improve their physical function. For older, obese, frail individuals, this could improve their CVD risk factors, quality of life, enhance their health; reduce their healthcare utilization, illness, and disability; and decrease their adverse geriatric outcomes. After completing these aims, the investigators expect that they will have proven that the community-based, peer-led weight loss program can improve both weight and physical function among older, obese AA women. This also could help other demographic groups with obesity and poor physical function. Eventually, it could help older adults maintain their health and independence in the community
Older African American (AA) women have the highest prevalence of both obesity and frailty. In academic, expert-led interventions, obese, frail, older individuals both lost weight and improved their physical function. However, because of high personnel costs and nonexistent nationwide infrastructure, large-scale implementation of these interventions is impractical. The long-term goals are to eliminate the health disparities of obesity and frailty in older AA women. This proposal's overall objective is to determine the effects of a low-cost, community-based, peer-led weight loss program with a national infrastructure on obesity, physical function, and healthcare utilization in older AA women. To treat obesity and frailty in older AA women, it is critical to test a weight loss intervention that 1) has preliminary evidence of benefit; 2) is acceptable to older AA women; 3) is affordable; and 4) can be broadly disseminated. Take Off Pounds Sensibly (TOPS) is a national, nonprofit, community-based, peer-led weight loss program that meets these criteria. First, the applicant's retrospective database analyses of TOPS showed two important results: 1) Participants who renew their annual membership lose and maintain significant weight loss (SWL) for up to 7 years; and 2) Compared to their younger counterparts, older women are more likely to achieve SWL. Second, the applicant started three TOPS chapters for older AA women in a successful pilot study. Though the study ended in 2012, one of the chapters is still active almost 6 years later. Third, TOPS is affordable; it only costs $120 annually. Finally, TOPS has a nationwide infrastructure with chapters in all 50 states. Since obese, frail, older individuals in academic, expert-led weight loss interventions can improve their physical function, the central hypothesis is that a low cost, community-based, peer-led weight loss program with a national infrastructure can provide SWL, improved physical function, and lower healthcare utilization for AA women, an underserved, vulnerable population. The rationale for the proposed research is that TOPS and academic, expert-led weight loss interventions share components critical to successful weight loss; therefore, TOPS can deliver similar outcomes. The central hypothesis will be tested by pursuing the following aims in obese, frail, older AA women: Determine the effect of TOPS on 1) weight change and cardiovascular disease risk factors; 2) physical function and quality of life; and 3) healthcare utilization. This project is innovative because it uses a "community to academia" approach to treat the health disparities; our study population focuses on older AA women with decreased physical function; our outcomes focus on weight, physical function, and healthcare utilization; and our unique study settings. The proposed research is significant because determining the real-world effectiveness of the TOPS program and its impact on weight, physical function, and healthcare utilization in AA women can have a widespread impact on the older population at large. Thus, it has the potential to reduce adverse geriatric outcomes among all older individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Dietitian-facilitated classes
At end of study, offered peer-led classes to attend.
Duke University
Durham, North Carolina, United States
Weight Change
Percent of body weight change over 6 months
Time frame: Baseline to 6 months
Systolic Blood Pressure (BP)
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
Diastolic Blood Pressure (BP)
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
Waist Circumference (WC)
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
Hemoglobin A1c (HA1c)
Percentage of hemoglobin that is coated with glucose. A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
HDL (High-Density Lipoprotein) Cholesterol
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Direct
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
Triglycerides
A measure of cardiovascular disease (CVD) risk.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Primary Care Visits
Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months).
Time frame: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months).
Time frame: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Hospitalizations
Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months).
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. Scores range from zero to 12 possible points. Lower scores are associated with lower function.
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by 8-ft Up and Go
The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving. Higher times are associated with worse physical function.
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Right Hand
Decreased grip strength is a predictor of adverse outcomes in older adults.
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Left Hand
Decreased grip strength is a predictor of adverse outcomes in older adults.
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by 30 Second Chair Stands
Counts the number of times a participant goes from sitting to standing in 30 seconds. Tests leg strength and endurance. Higher number associated with higher leg strength and endurance.
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by 6 Minute Walk Test
Measures distance walked in 6 minutes and assesses aerobic capacity and endurance. Higher number indicates higher aerobic capacity and endurance.
Time frame: Baseline, 3 months, 6 months
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