Introduction

The prevalence of overweight in the United States has risen steadily over the past generation from 25.4% in the 1980 National Health and Nutrition Examination Survey to 33.3% in the 1991 survey, to its current staggering level of >50% based on the latest survey (1, 2, 3, 4, 5). Excessive dietary intake of calorie-dense, high-fat foods and progressively sedentary lifestyles are thought to contribute to 300,000 deaths/y, second only to smoking as a cause of preventable death (6). In the inner-city indigent population, obesity exceeds 50% and type III obesity (body mass index > 35 to 39 kg/m²) (4) is approaching 20% (6). Obesity is most prevalent in adult non-Hispanic black women, Mexican-American men and women, and Hispanic men (7). Black women have twice the rate of obesity as do white women (7, 8). The rate of hypertension, stroke, coronary artery disease, and diabetes among black women is 1.5 to 2.5 times that of white women (8). Unfortunately, few weight-loss strategies and programs have been targeted to black and inner-city Americans.

Our previous experience with the very-low-calorie formula diet (VLCD) using OPTIFAST (9, 10, 11) suggested that this approach might be a particularly attractive modality in treating type III obesity in the inner-city: rapid weight loss of 20 to 30 lbs can often be obtained within 1 month using this method, making it more likely to achieve a modest goal of 10% weight loss; the outlook for substantial weight loss of 50 to 100 lbs is within reach for the motivated patient; and our contention that reliance on high-fat-containing fast foods have become so engrained in the inner-city diet that it would be easier for our inner-city patients to undergo total withdrawal from food vs. an approach that offers lesser amounts of low-calorie, low-fat diets of 1000 to 1200 kcal advocated by the National Heart, Lung, and Blood Institute in their guidelines (4). The major drawback to the use of the VLCD is the high cost of the protein supplements. This problem was obviated by a grant from the Healthcare Foundation of NJ and partial support from Novartis Nutrition, which enabled us to deliver all services free-of-charge for qualifying patients. We report our findings, using the VLCD in treatment of type III obesity in inner-city patients.

Research Methods and Procedures

Patient Eligibility

Adult men and women were accepted into the Obesity Program if they met the following eligibility criteria:

• Weight at least 80 lbs over ideal body weight (using Metropolitan Life Insurance Tables)

• Age over 18 years

• No recent history of stroke or myocardial infarction (3 month minimum)

• No active chemotherapy for malignancy (adjuvant use of Tamoxifen was acceptable)

• No active schizophrenia

Patients needed to demonstrate lack of financial means to pay for program. Such criteria included: Medicaid eligibility card, Charity Care, Social Security income, and/or total household income less that two times the Federal Poverty Guidelines.

All primary care physicians practicing in the Newark area and vicinity were informed of this VLCD program available to their indigent patients. Patients referred to the program were invited to an orientation session to hear about the program, ask questions, and determine whether they wanted to pursue this approach. All patients accepted into our program were required to have referral letters from their primary care physician. Institutional Review Board approval was obtained and all patients enrolled in the study signed the informed consent.

Treatment Goals

We defined success as 10% weight loss (4) within 10 weeks after starting the VLCD. Our previous data suggested that patients on this VLCD should achieve 10% loss of initial weight after 5 to 7 weeks (11). A nonsuccessful patient was defined as a patient who dropped out or did not achieve 10% weight loss after 10 weeks. Because gender distribution in our inner-city patients favored women vs. men 9:1, our study is confined to an analysis of weight loss in women only.

Therapeutic Plans.

We used three treatment paradigms in an attempt to determine which approach would yield the highest success rates of weight loss.

Group A consisted of 49 consecutive women recruited from January 8, 1998 through March 19, 1998 into a total cost-free program for 10 weeks. Patients who were successful in achieving their goal of 10% weight loss were offered a maintenance program, but all patients preferred to remain in the weight-loss phase and they were supported for additional 5-week blocks based on continued progress.

Group B consisted of 43 consecutive women enrolled from September 17, 1998 through February 4, 1999 (no recruitment was made between November 5, 1999 and January 5, 1999 due to holidays). These patients were accepted into a cost-free program but were required to meet some minimal goals to remain in the program. These goal requirements consisted of:

1. Patient had to lose weight (any amount) during the first week.

2. Patient had to attend clinic every week. Two consecutive absences from clinic resulted in disqualification.

3. Patients had to lose weight every week. Failure to lose weight on 2 successive weeks resulted in disqualification from the program.

4. Patients who completed at least 10% weight loss after 10 weeks were offered maintenance; however, all patients requested and were granted an additional 5 weeks of continued weight loss and reevaluation for a possible second 5-week period. Patients not completing 10% weight loss after the initial 10 weeks were informed of their disqualification.

All patients in group B were informed of the compliance requirements and signed an agreement of understanding before beginning the program.

Group C consisted of 39 consecutive women recruited from March 26, 1998 through June 18, 1998 and were required to pay $25/week for their OPTIFAST. The charge was established as a minimal barrier and was less than the average cost of $60 to $70/week charged to nonindigent patients. No compliance restrictions were placed on this group as described in group B.

The suburban group consisted of 45 consecutive women enrolled from January 1998 through October 1999 into an identical for-pay program located in Roseland, NJ during the same time frame as our inner-city program. This suburban program contained the same educational curriculum and was run by the same counselors as our program but served an affluent suburban population.

The historical control group consisted of 42 women whose last name began with the letter "N" registered in our former program at Newark Beth Israel Medical Center from 1985 through 1995. The letter "N" was randomly drawn from 1500 patient charts accrued from 1985 through 1995 and not previously reported. This provided a second control group of affluent women for comparison to our inner-city patients. The same counselors, education activity, and program director (M.A.K.) served this patient group, but patients received 400 kcal/d (OPTIFAST 70) vs. an 800-kcal supplement in the other four groups.

Details of the VLCD Program.

At entry into the program, all patients were evaluated by an extensive medical history, physical examination, electrocardiogram, complete blood count, serum chemistry, lipid profile, and most had basal thyroid function tests, which proved normal. All food was stopped except diet sodas, black coffee, tea, and noncaloric drinks. OPTIFAST-800 (Sandoz Nutrition, Minneapolis, MN; five servings of 160 calories per packet) formula consisted of 70 g/d of protein (from a pasteurized egg white, calcium casein, and nonfat dry milk source), 30 g of carbohydrate, and 15 g of fat with 1000 mg of calcium, 100% recommended dietary allowance of vitamins, trace elements, and 20-mEq potassium supplements. The OPTIFAST was blended with a noncaloric beverage, such as water or diet soda, and was taken five times a day, duplicating three meals and two snacks. As noted above, the historical control group received a lower kilocalorie diet in use at the time (OPTIFAST 70). Both dietary supplements contained 70 g of high-quality proteins.

Patients were seen weekly at the clinic for medical monitoring of weight loss, blood pressure, and for monitoring coexisting medical problems and/or adjusting drug regimens. Complete blood count and blood chemistries were repeated every few weeks, and electrocardiograms were performed as indicated. Diabetic patients were carefully monitored during the early weeks of weight loss, with downward adjustment of insulin and/or oral hypoglycemics based on self-monitored reporting and frequent assessment of blood sugar and glycohemoglobin.

Support Group and Nutritional Education Sessions.

Group sessions were conducted by our patient counselor (M.S.W.) and dietitian during clinic hours. These sessions consisted of traditional behavior modification teaching, body image, coping strategies, low-calorie planning, value of exercise, and handling vacations and holidays.

Results

We treated a total of 131 morbidly obese inner-city women using three treatment schedules, outlined in the previous section and noted in Table 1 . The inner-city patients had higher starting weights compared with the suburban and historical control groups with average body mass indexes of 50.3 0.9 kg/m² vs. 40.9 1.5 kg/m², respectively, and 39.7 1.3 kg/m² in the historical controls. The inner-city patient groups exhibited a higher incidence of diabetes mellitus (25%) compared with the two control groups (8%). The incidence of hypertension and dyslipidemia was comparable in urban and suburban groups as shown in Table 1.

Table 1 - Characteristics of inner-city vs. suburban morbidly obese women.

Full table

During the initial week of the VLCD, the average weight loss for treatment group A, B, C, and S was comparable, ranging from 6.5 to 7.1 lbs, representing 2% to 3% of starting weight as shown in Table 2 . The historical control group exhibited greater weight loss at each point, reflecting the lower-calorie content in their diet.

Table 2 - Weight loss in inner-city vs. suburban women.

Full table

After the first week, patient compliance and dropout rate varied considerably among the treatment groups, as presented in Figure 1 . Group A had a low attrition rate after 10 weeks; however, only 18% of patients in this group successfully achieved the goal of 10% weight loss. Imposing compliance criteria (group B) resulted in accelerated dropout rates, such that only 37% of the starting group remained in the program after 10 weeks; and 16% of the patients in this group achieved the goal of 10% weight loss. It should be pointed out that only 3 of the 43 patients in this group were actually disqualified. A total of 25 of the 43 patients dropped out. When a modest financial charge was imposed (group C), 38% of patients completed the 10-week program but only 10% of patients were successful in achieving the 10% weight loss goal. Thus, altering the treatment paradigms influenced dropout rates but had no significant effect on changing the success rates.

Figure 1.

The percentage of obese patients completing 10 weeks of VLCD and the percentage achieving 10% weight loss in inner-city vs. suburban patients.

Full figure and legend (43K)

In comparison to the inner-city patient groups A–C, the suburban group and historical controls paying full fare exhibited 67% and 76% completion rates after 10 weeks and 33% and 55% were successful in achieving 10% weight loss, approximately twice that observed for the three inner-city groups. The weight loss in our five study groups was most reflected by compliance with the program. A notable exception occurred in the women in group A, who were receiving all services free of charge without any pressure, resulting in high completion rates of 79%, but poor success rates in achieving 10% weight loss. The greater weight loss achieved in the historical control group can be explained by greater compliance rates combined with a lower-calorie content in the diet.

Discussion

The health consequences of obesity are well known. There is an increased incidence of hypertension, diabetes mellitus, coronary artery disease, peripheral vascular disease, and gallbladder disease (4, 6, 8, 11, 12, 13, 14, 15). Obesity is a prominent contributory factor in sleep apnea, osteoarthritis, pregnancy complications, and several cancers and is an independent risk factor for death (16). The consensus conference held at the National Institute of Health in 1985 suggested that morbid obesity or 100 lbs above ideal body weight should be considered as a distinct entity (17) associated with 6- to 12-fold increase in mortality rates (18). The economic impact of obesity is similarly staggering, both in terms of increased costs for managing the associated illnesses as well as loss of manpower productivity and has been estimated to be approaching $100 billion per year (19, 20, 21).

Despite the mounting prevalence of type III obesity, its impact on health, and its costs, few new approaches to weight loss have come forth. Nutritional counseling aimed at calorie restriction and consumption of the idealized diet has been the backbone of most attempts at weight control. A variety of appetite-suppressant medications have been available with several new entries to the field in the recent years but none has emerged as a fully effective therapy free of major side-effects (22, 23, 24, 25, 26). The recent National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases Obesity Education initiative continues to recommend a calorie-restrictive diet of 1100 kcal/d with lifestyle changes of exercise and behavioral changes (4). Unfortunately, low-calorie diets have been shown to have extremely low success rates in people requiring >40 lbs of weight loss (27, 28). In the inner-city population, where high-fat diets are engrained as a way of life, this approach will be even more difficult. Exercise is often precluded in the inner-city population, where street safety is a grave concern and indoor exercise facilities are only a dream.

The use of VLCD of 600 to 800 kcal/d of protein supplements has offered the potential of achieving greater amounts of weight loss than attainable by simple caloric restriction (9, 10, 11, 29). Weight losses of 60 to 100 lbs can be regularly achieved by those dedicated obese patients willing to undergo the social deprivation of eating regular meals. Weight loss has been associated with considerable decreases in resting energy expenditure (30), tending to facilitate regain when the hypocaloric effort is completed. It remains unsettled whether rapid weight loss via VLCD promotes greater degrees of weight regain then slow loss via caloric restriction. What seems clear is that exacerbation of obesity after weight loss is an ever-present problem that needs to be dealt with in all weight management efforts (24, 31, 32, 33). Furthermore, additional or periodic courses of weight control therapy (weight cycling) seems to have no particular adverse outcomes (34, 35, 36) and for the present, may have to be part of the long-term treatment strategy of obesity control, similar to cycles of chemotherapy for recurrent malignancy or repeated cycles of corticosteroids for rheumatic or allergic exacerbations.

We have had long-standing interest in bringing the VLCD approach to the inner-city population, which has been remarkably excluded from weight loss efforts because of financial barriers. In 1998, we launched a cost-free obesity control program for inner-city residents of Newark, NJ. We explored three treatment paradigms, which were offered consecutively to cohorts of 50 patients, enabling us to determine whether compliance requirements or financial outlay would stimulate/impede success rate. The experience with our three treatment groups were compared with success rates achieved in patients enrolled in a parallel suburban OPTIFAST Program, located in Roseland, NJ (courtesy of G. Schneider). We were fully aware that the design of the cohort study is inferior to that of a randomized clinical trial; however, the logistics of treating paying patients vs. nonpaying patients simultaneously would have negatively impacted on patient compliance.

The results of our studies demonstrated that early weight loss was similar in all groups, but after 10 weeks, the three inner-city groups were only half as successful in achieving 10% weight loss compared with suburban patients because of increased of number of dropouts. Of those women who remained in the program, weight loss was comparable in the inner-city vs. suburban patients. By contrast, the completion rate and success rate of the two affluent suburban groups were twice that noted for the inner-city women.

As presented earlier, the inner-city groups had a higher incidence of diabetes compared with the two control suburban groups; however, as shown in Table 2, early weight loss over the first 4 weeks was comparable in the inner-city vs. suburban women, making it highly unlikely that an increased incidence of diabetes in the inner-city women represented a significant impediment to weight loss.

Our studies to date show that only 20 of 131 of our morbidly obese inner-city patients (15%) achieved the modest goal of 10% reduction of weight using the VLCD approach. The success rate reported here is still at least twice that observed in earlier reports using conventional low-calorie diets (27, 28). Furthermore, in the present study of inner-city patients (groups A to C) we observed improved glycemic control in 87% of diabetic patients who lost 10% of their weight, evidenced by lowered requirements for hypoglycemic agents. Similarly, hypertension decreased in all patients after 10% weight loss, and dyslipidemia was improved in 80% of successful patients, similar to our previous findings (9, 10, 11) and supporting observations of the health benefits of 10% weight loss (37). At this point, we must conclude that innovative treatment paradigms are necessary when dealing with inner-city patients. Financial outlay, which may serve as a stimulus to weight loss compliance in the affluent population (11), had no stimulatory effect in the indigent inner-city patients. Compliance limits similarly acted as a turnoff. Wing et al. (38) reported that positive financial incentives did not improve weight loss in their population; however, in the indigent group, a potential beneficial effect of positive financial stimuli cannot be ruled out.

Finally, it should be pointed out that use of the VLCD approach has considerable drawbacks. It is labor-intensive, requiring at least two physicians, a patient counselor (Medical Social Worker) and a registered dietitian to deliver these weight loss services described. The cost of quality protein supplements adds considerable expense, which is generally beyond the financial means of the indigent. Finally, the reimbursement from unsympathetic health maintenance organizations serving the indigent population precludes any chance of recouping costs. We estimate a cost of $150,000 to provide this VLCD program to 170 indigent patients or $5300 for each successful patient. These financial estimates to care for the indigent obese are staggering; they call for new methodology to control type III obesity in the inner-city. These estimates, however, are a fraction of societal costs to care for the metabolic and subsequent disease consequences of the rampant obesity.

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Acknowledgments

This work was supported by grants from the Healthcare Foundation of New Jersey, Roseland, NJ and Novartis Nutrition, Minneapolis, MN. We thank George Schneider, Metabolic and Nutrition Service, Roseland, NJ for making his data available to the study. We also thank Marie Pisaneschi, Julia Jaskiewicz, and Marsha Taylor for their assistance.