Introduction

Obesity is growing in prevalence among older persons. The National Health and Nutrition Examination Survey 1999 to 2000 found that 38.1% of men and 42.5% of women between 60 and 69 years of age were obese (BMI 30 kg/m²) (1). The corresponding figures are 28.9% of men and 31.9% of women between the ages of 70 and 79 years. At 80 years or greater, the prevalence of obesity declines precipitously. Excess weight and obesity are associated with serious medical comorbidities that afflict older persons, including hypertension, diabetes, dyslipidemia, and coronary artery disease (2,3,4,5).

Among older persons, high BMI is also associated with increased self-reported functional limitations, decreased physical performance, and elevated risk of subsequent functional decline (6,7,8,9). An obese Medicare participant costs $1486 more in healthcare expenditures per year than one of healthy weight (10), likely reflecting associated disease burden and functional decline.

There has been considerable controversy regarding recommendation for weight reduction for obese older persons and a paucity of research that addresses this concern. Weight loss in cohort studies of older persons has generally been associated with adverse outcomes (11). This may be related to underlying disease or inflammatory processes because it has been difficult to distinguish volitional from non-volitional weight loss (12,13). Some studies have suggested that middle-aged women who achieve a modest weight loss of 5 kg can reduce their risk of developing hypertension, diabetes, or osteoarthritis later in life (2,5,14). A cohort investigation of weight change in older women in the Nurses Health Study found that weight loss among overweight/obese women was associated with improvements in self-reported physical function and vitality and lower levels of bodily pain (13).

Intervention studies promoting weight loss in older people have been extremely limited. The Trial of Nonpharmacologic Interventions in the Elderly (TONE),¹ a randomized, controlled trial of 36-month duration, was conducted to compare the efficacy of either reduced sodium intake, weight loss, both, or usual care in the treatment of hypertension in older people (n = 975) (15). Investigators concluded that it is feasible to achieve and maintain moderate decreases in sodium intakes and body weight in elderly people with hypertension. These changes are associated with a reduction in the amount of antihypertensive medication needed. In another randomized clinical trial, Messier et al. (16) compared the effects of a 24-week exercise and diet program with exercise alone on obese older adults diagnosed with knee osteoarthritis (n = 24). Both programs resulted in moderate weight loss over a 6-month period. Improvements in knee pain, self-reported disability, and physical performance were also observed.

These limited studies on intentional weight loss have targeted specific high-risk subgroups of the elderly. The feasibility or desirability of weight reduction interventions for older persons remains unclear. The objectives of this pilot study were to determine the feasibility of a 3-month medical weight loss program for community-dwelling obese older women with short-term measurements of relevant laboratory, physical performance, functional, and life quality outcomes. Women were selected because of their higher rates of obesity and associated disability in this age group (1,8).

Research Methods and Procedures

Study Participants

Participants were recruited through local print, electronic, and television advertising in Nashville, TN. To be eligible, participants had to be women 60 years and older with a BMI of 30 kg/m² or greater. Other selection criteria were to be community-dwelling, be ambulatory, have a telephone, and be reasonably expected to survive 12-months. The study was approved by the Vanderbilt University Institutional Review Board, and all participants signed informed consent at time of enrollment.

Medical Weight Loss Program

Participants were enrolled in a 3-month weight loss program that was provided free of charge. The program consisted of a baseline assessment by a bariatric physician followed by eight counseling visits (30 minutes each) with a dietitian and a follow-up physician visit on completion. Standard interventions included prudent diet, behavior modification, and physical activity.

Participants were encouraged to reduce their caloric intake to between 1200 and 1500 kcal/d (comprised of 55% carbohydrate, 20% to 30% fat, and 15% to 20% protein). They were also asked to take multivitamins with minerals and calcium/vitamin D supplements and consume two to three servings of calcium rich foods a day as well as foods high in vitamin B12 and folic acid. Tolerance to milk products was queried. Each participant was asked to maintain a food and activity diary throughout the program. Amount and description of food consumed, calorie count, level of hunger, and mood were recorded. A pedometer (Accusplit, San Jose, CA) was provided to each subject, and daily numbers of steps were recorded. It was elected to target a moderate goal of at least 5000 steps per day in view of participants' age and obesity. Weight was obtained at each follow-up visit, and the food and activity diary was reviewed with the dietitian. New goals were based on diary reports. The diary was used primarily as an educational instrument to make participants aware of their behaviors and was not considered as a research instrument. The emphasis of the program was on health, function, and quality of life with a goal of achieving a moderate 5% reduction in body weight by 3-month follow-up. Patient education materials were printed in large font at an eighth grade level. All visits took place at the Vanderbilt Center for Human Nutrition (Nashville, TN).

Measures

Laboratory, functional, and life quality assessments were completed at baseline and at 3-month follow-up visits. These assessments included: physical examination by a bariatric physician, anthropometrics, laboratories, body composition, physical performance, the Medical Outcomes Study Short-Form 36 Health Status Survey (SF-36) (17), and the Life Space Assessment (LSA) questionnaire (18,19).

Anthropometric measurements, consisting of weight, height, BMI, and waist-to-hip ratio, were conducted in triplicate and averaged to increase accuracy. Weights and heights were measured without overgarments or shoes on a digital scale (model 5002; Scale-Tronix, White Plains, NY) and with a wall-mounted stadiometer (model 216; Seca Corporation, Hanover, MD), respectively. Consistent with standard care for the weight loss program, laboratories included: lipid panel [total cholesterol, low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and triglycerides], fasting blood sugar, and hemoglobin A_1c (HbA_1c). These laboratory tests were conducted by the fully accredited Vanderbilt clinical laboratories using standard automated procedures.

Bioelectrical impedance analysis (analyzer model 101A; RJL Systems, Clinton Township, MI) was used to assess body composition. Each subject was placed in supine position for the procedure, and electrodes were attached to the right hand and foot according to the manufacturer's instructions. Fat-free mass (FFM) was calculated using the Haapala formula (FFM = -128.06 + 1.85 BMI - 0.63 weight + 1.07 height - 0.03 resistance + 10.0 waist-to-hip ratio). This equation was developed and validated for use with older women, including overweight and obese subjects (20).

Physical performance was measured with a modified set of physical tasks developed and validated for obese older persons (7,21). Tasks included: put on and remove a jacket, a 15-meter walk, lift and move a 10-lb weight, step climb and descent (3), pick up a penny from the floor, repeated chair stands (5), and a 400-meter walk. Subjects were not allowed to use assistance devices during the test except for the 15- and 400-meter walks. General instructions and demonstrations were given before each task. All tasks were timed with a stopwatch, with start and endpoints rigorously defined. A score was attributed according to the time required to perform the task (ranging from 0 to 4 for a total score ranging between 0 and 28). All participants received medical clearance for the testing at baseline.

Both the SF-36 and the LSA were administered at baseline and follow-up. The SF-36 aims to display a profile of health status that covers eight domains: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, social functioning, emotional well being, vitality, and health. Each domain was scored independently from 0 (lowest level of functioning) to 100 (highest level of functioning). The SF-36 is a validated instrument and has been widely applied (17). The LSA provides an assessment of mobility and functioning (18). It is focused on five concentric life spaces (home, outside the home, neighborhood, town, outside of town). It queries the frequency of being in these spaces over the prior month and whether an assistance device or the help of another person was required to get there. This instrument has been developed and validated with a population of older persons (19).

Dietary Assessment

A dietary assessment, consisting of three telephone-administered, nonconsecutive (2 weekdays and 1 weekend day) 24-hour dietary recalls, was completed by a research dietitian in the 2 weeks after the baseline visit. A multiple-pass approach that prompts for food description, detailed food preparation methods, portion descriptions, and supplement consumption was used. Patients were given a food portion visual aid that they used while completing the recalls. Data were entered into a dietary assessment software system (NDS-R, version 4.03; Nutrition Coordinating Center, Minneapolis, MN) during the interview. Three-day energy and nutrient intakes were averaged.

Statistical Analysis

Descriptive statistics (mean and SD for continuous data; frequency and percentage for categorical data) were determined at baseline and follow-up. Comparisons between baseline and follow-up measurements were calculated using the Wilcoxon Signed Rank Test for paired continuous data and with the McNemar test for paired categorical data. Analyses were performed using the SPSS/PC statistical program (version 11.5.0 for Windows; SPSS, Inc., Chicago, IL).

Results

Forty-six subjects were eligible and invited to enter the study. Of this number, 26 accepted and signed the informed consent. Reasons for not participating were related to schedule conflicts/transportation problems or lack of interest. Eight participants (31%) withdrew post enrollment. The primary reason for withdrawal was inability to return for visits because of illness (either personal or close relative). Eighteen (69%) participants completed the 3-month weight loss program. There were no statistically significant differences at baseline among the women who completed the study (n = 18) and those who withdrew (n = 8) except for the number of medications taken daily (7.5 3.1 vs. 6.9 6.9, p = 0.046, respectively).

Sixteen participants who completed the study were non-Hispanic white women, and two were African Americans. Participants were between 60 and 75 years of age, and the mean age was 64.1 years (4.8). Educational level was high school or higher. At baseline, there were an average of 3.2 (1.3) obesity comorbidities (musculoskeletal pain and osteoarthritis, gastroesophageal reflux, sleep apnea, gallstone, hypertension, cardiovascular disease, dyslipidemia, hiatal hernia, deep vein thrombosis, gout, asthma, plantar fasciitis, stress incontinence, musculoskeletal pain) per participant. Thirteen (72.2%) presented with a history of hypertension and seven (38.9%) with a history of dyslipidemia. One woman (5.6%) had a history of diabetes, and two (11.1%) had elevated fasting blood glucose (>110 mg/dL) at baseline. Seven subjects (38.9%) presented with history of metabolic syndrome according to the National Cholesterol Education Program guidelines (22). On average, participants reported taking 7.5 (3.1) different medications daily. Seventeen subjects (94.4%) reported previous weight loss efforts, and six (33.3%) stated that they were engaged in regular physical activity. Mean daily caloric intakes were estimated from the diet recalls at 1785 kcal (467), composed of 34% fat, 53% carbohydrate, and 13% protein. Dietary reference intakes (DRIs) were met for all nutrients except for total dietary fiber (90% of DRI) and vitamin D (78% of DRI) (23,24).

Table 1 reports measures taken at baseline and follow-up for the subjects who completed the intervention. There was a significant decrease in mean body weight (100 15 vs. 96 18 kg, p = 0.006), with a mean weight loss of 4.3 (5.5) kg. This reflects an average reduction of 4.5% (5.3) from baseline. Eight women (44.4%) achieved a 5% weight loss, whereas seven (38.9%) achieved a 1% to 5% weight loss. Three participants (16.7%) gained weight. All anthropometric (except for waist-to-hip ratio) and body composition parameters, including FM and FFM, decreased significantly. There were significant improvements in diastolic blood pressure, total blood cholesterol and triglycerides and nonsignificant reductions in systolic blood pressure, LDL-C, HDL-C, and cholesterol-to-HDL-C ratio. Medications that would impact lipid or blood pressure parameters were not changed over the study period, nor were there significant changes in total medication numbers. There was a nonsignificant increase in the number of participants who reported taking a daily multivitamin supplement [baseline n = 6 (33.3%) vs. follow-up n = 10 (55.6%)].

Table 1 - Comparison between baseline and follow-up.

Full table

Self-reported pedometer readings were 4000 steps daily at baseline (Table 1). At follow-up, there was a modest, but significant, improvement in the reported number of daily steps. The overall physical performance score improved significantly at follow-up (Table 1). When each physical task was examined individually, participants performed particularly better at follow-up on step climb and descent (baseline 20.6 8.5 seconds vs. follow-up 18.5 7.9 seconds, p = 0.003). Likewise, self-rated SF-36 physical functioning subscore was significantly improved (Table 1). Participants also reported significant improvements in their vitality levels on the SF-36. Mobility, as measured by the LSA, remained unchanged.

Discussion

This pilot investigation demonstrated that it is feasible to achieve a moderate weight reduction in obese older women who complete a short-term weight management program. The program was a combination of prudent diet, behavioral modification, and physical activity. The primary emphasis of the program was on health, function, and quality of life. The approach was tailored specifically to older subjects through use of large-font instructional materials, supplezhy;eb;n;jmentation of calcium and vitamin D, and moderate weight loss and physical activity prescriptions. Weight reduction programs have yielded similar results with comparable drop-out rates in young and middle-aged adults (25).

The mean weight reduction, percentage of weight loss, and decrease in diastolic blood pressure among those who completed the program are comparable with those observed in the TONE trial (15). Moreover, significant decreases were observed in total cholesterol and triglyceride levels. Such improvements have also been seen in a younger sample of overweight postmenopausal women (mean age 53.8 2.5 years, mean BMI 29.7 3.1 kg/m²) randomly assigned to diet or diet and exercise groups compared with a non-intervention group (26). There was no change in fasting blood sugar and HbA_1c in our sample, but most baseline values were normal.

Obesity is associated with increased reporting of functional limitations, decreased measured physical performance, and increased risk of functional decline among obese older persons (7,13). Self-rated physical functioning and vitality, as measured by the SF-36, were significantly improved in our study at follow-up. Cohort findings from The Nurse's Health Study suggest that weight loss is associated with improvements in SF-36's physical functioning and vitality dimensions (13). Moreover, other studies have found that overweight is associated with self-reported physical limitations and higher levels of pain in populations with knee osteoarthritis (9,16). Although not quite significant, we observed a trend toward improvement in self-reported levels of pain.

We observed improvements in overall physical performance score, particularly in step climbing. Similar results on step climb have been observed in a group of obese older persons with knee osteoarthritis after a 6-month weight reduction program consisting of diet and aerobic/strength training (16). Improvements in physical performance and in pain and disability were attributed to the combination of weight loss and aerobic and strength training rather than to weight loss alone.

We observed no change in mobility at follow-up as measured with the LSA. However, at baseline, only a minority of participants reported that they needed the help of an assistance device or person (independent and assisted life spaces) to get outside their home, neighborhood, or town (data not shown).

Whether improvements observed in this study outweigh the potential risks associated with weight loss in old age remains unclear. An ancillary study to the TONE trial found that weight loss in postmenopausal women is associated with a modest reduction in total body bone mineral density (27). DXA was not available for this limited pilot study. Promoting calcium supplementation and physical activity may be important to decrease bone mineral loss.

In our study, there was a small but significant decrease in FFM between baseline and follow-up. This is consistent with reports for younger women enrolled in weight management programs (28,29). The modest decrease observed in our study apparently did not have any detectable negative impact on measured or self-reported physical and functional parameters on a short-term basis. Resistance and strength training may be helpful to preserve muscle mass in this setting.

Obese older women represent a nutritionally vulnerable group. Unhealthy dietary patterns, poor diet quality, and micronutrient deficiencies have been observed in a prior study of obese older women who were homebound (30). However, this was not evident in our present sample at baseline. When compared with current DRIs, dietary intakes were inadequate for vitamin D and fiber only. Women participating in our study were 60 to 75 years old and were not frail or homebound. As part of the program, participants were encouraged to take supplements and to eat whole-grain foods and foods rich in calcium and vitamin D. It would seem that emphasis on a vitamin D supplement is warranted because a number of participants took calcium supplements only. Because reduced calorie diets could exacerbate nutritional problems in older persons, dietary intervention should be oriented toward improving diet quality by increasing intake of nutrient-dense foods such as fruits, vegetables, and calcium-rich foods while reducing consumption of energy-dense foods.

Strengths of this pilot investigation include the use of a well-standardized comprehensive weight loss intervention with validated laboratory, functional, and life quality outcome measures. Each subject served as her own control. Given the high number of independent measures acquired in this study, the possibility of Type I error cannot be excluded. Although it is possible that observed improvements in outcome measures resulted from unknown factors, it is likely that moderate weight reduction and increase in physical activity levels (mostly walking) were key factors. This study included women 60 to 75 years old; therefore, results may not be applicable to men or to appreciably older women. Our sample consisted of fairly robust self-selected participants who suffered only moderate functional limitations and disease burden at baseline. It is also not evident that maintenance of weight reduction and associated benefits can be achieved without continued intervention.

Very few studies have addressed weight reduction and maintenance for older persons. Thus, there is a great need for long-term investigation so that obese older persons, their caregivers, and allied health practitioners can make prudent decisions in regard to potential weight reduction interventions. As per the NIH guidelines, weight loss management in older people should be guided by an evaluation of potential risks and benefits for each individual patient (25). A combination of prudent diet, behavior modification, and increased levels of physical activity/exercise may be suitable for selected candidates. As shown in our study, improvements in cholesterol, triglycerides, diastolic blood pressure, physical performance, self-reported functioning, and life quality may result. For obese older persons with severe frailty, the emphasis may be better placed not on weight reduction but on preservation of strength and flexibility.

Notes

¹ Nonstandard abbreviations: TONE, Trial of Nonpharmacologic Interventions in the Elderly; SF-36, Medical Outcomes Study Short-Form 36 Health Status Survey; LSA, Life Space Assessment; LDL-C, low-density lipoprotein-cholesterol; HDL-C, high-density lipoprotein-cholesterol; HbA_1c, hemoglobin A_1c; FM, fat mass; DRI, dietary reference intake; FFM, fat-free mass.

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Acknowledgments

We thank Robin Lapré for her participation in the physical assessment of our participants. This work was supported in part by an unrestricted grant from Nestle Nutrition and in part by the Veterans Affairs Tennessee Valley Geriatic Research and Education Clinical Center and NIH Grant DK26657.