Original Article

International Journal of Obesity (2007) 31, 488–493. doi:10.1038/sj.ijo.0803423; published online 4 July 2006

Weight loss and long-term follow-up of severely obese individuals treated with an intense behavioral program

J W Anderson1, L Grant2, L Gotthelf2 and L T P Stifler2

  1. 1Department of Internal Medicine, College of Medicine, University of Kentucky and Health Management Resources Weight Management Program at the University of Kentucky, Lexington, KY, USA
  2. 2Health Management Resources, Boston, MA, USA

Correspondence: Dr JW Anderson, Department of Internal Medicine, College of Medicine, University of Kentucky Medical Center, and Health Management Resources Weight Management Program at the University of Kentucky, Room 524, Lexington, KY 40536-0298, USA. E-mail: janders@uky.edu

Received 2 October 2005; Revised 1 May 2006; Accepted 14 May 2006; Published online 4 July 2006.

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Abstract

Objective:

 

To review weight loss and maintenance for severely obese individuals enrolled in intensive behavioral weight loss program using very-low or low-energy diets.

Design:

 

Chart review of consecutively treated patients between 1995 and 2002 seen at three weight loss centers.

Subjects:

 

One thousand five hundred and thirty one patients with severe obesity (greater than or equal to40 kg/m2) treated in three cities ('Study Group'). Of these, 1100 completed the 12-week core curriculum ('Completer Group'). Weight loss greater than or equal to100 lbs (>45 kg) was seen in 268 patients ('100-Pound Group').

Measurements:

 

Charts were reviewed for baseline characteristics, weekly weights, follow-up weights and side effects.

Results:

 

In the Study Group, average weight lossplusminuss.e. for 998 women was 23.9plusminus0.6 kg (18.5% of initial body weight (IBW)) and for 533 men was 36.0plusminus1.0 kg (22.5%) over 30 weeks. For Completers, average weight loss for women was 30.8plusminus0.6 kg (23.9%) and for men was 42.6plusminus1.1 kg (26.7%) over 39 weeks. In the 100-Pound Group, average weight loss for women was 58.2plusminus1.2 kg (41.5%) in 65 weeks and for men was 65.7plusminus1.5 kg (37.5%) in 51 weeks. Side effects, assessed in 100 patients losing >45 kg, were mild to moderate in severity. Severe adverse events unrelated to the diet were noted in 5% of patients and during weight loss 1% had elective cholecystectomies. Follow-up weights were available for 86% of Completers at an average of 72 weeks with average maintenance of 23 kg or 59% of weight loss; follow-up weights were available for 94% of the 100-Pound Group at an average of 95 weeks with average maintenance of 41 kg or 65% of weight loss maintained.

Conclusions:

 

Intensive behavioral treatment with meal replacements is a safe and effective weight-loss strategy for selected severely obese individuals.

Keywords:

intensive treatment, weight loss, weight maintenance, meal replacements

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Introduction

Severe obesity is increasing in prevalence in the United States and worldwide.1, 2 Bariatric surgery is often recommended as the treatment of choice for many individuals with severe obesity (body mass index (BMI) greater than or equal to40 kg/m2) – also termed Class 3, extreme or morbid obesity.3, 4 In 2004, an estimated 140 000 persons had bariatric surgery in the US with a mortality rate of approx1% and an adverse event rate of approx20%.4, 5 Our recent experience with an intense, medically supervised behavioral program indicates that a substantial number of severely obese individuals successfully lose >45 kg (greater than or equal to100 lbs) and maintain considerable weight loss for long-term periods.6, 7 We reviewed the experience of severely obese patients treated at three centers with intense behavioral programs and are reporting these data. These observations suggest that intense behavioral treatment is an effective intervention for selected severely obese individuals and is associated with less risk than bariatric surgery.4, 8

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Materials and methods

Health Management Resources (HMR®) provides training, support services and meal replacement products for hospitals, medical centers and clinics throughout the United States. Three training centers – University of Kentucky, Newton, MA and Fort Worth, TX – have submitted weekly data from all individual patients enrolled since 1995. This report summarizes data for consecutive patients enrolled at these three centers from January 1, 1995 to December 31, 2002. During this 8-year period, a total of 3853 obese individuals (BMI greater than or equal to30 kg/m2) attended at least an initial and a follow-up class. The data submitted weekly include demographic information, attendance, weight change and weekly behavioral data. These data are entered into a database maintained at the HMR Corporate Office in Boston, MA, USA.

Treatment options available for patients with BMIgreater than or equal to40 kg/m2 include: Medically Supervised; Healthy Solutions®; and HMR at Home®. The Medically Supervised option – using very-low-energy diets (VLED) or low-energy diets (LED) – prescribes only meal replacement use during the weight loss phase. More than 85% of the patients were treated with LED and <5% received pharmacotherapy for obesity (chiefly phentermine). Patients are instructed to use a minimum of five shakes or three shakes plus two entrees daily; they are encouraged to use additional meal replacements (shakes, entrees or bars) as necessary. Medically Supervised patients are seen weekly by a program physician for 4 weeks and then biweekly throughout the weight loss phase; laboratory measurements (chemistry panel, lipid profile, and hematology panel) are carried out biweekly or monthly during weight loss. The Healthy Solutions option does not require medical supervision or laboratory measurements for most patients; patients are encouraged to use three shakes, two entrees and five servings of fruits or vegetables daily. Patients enrolled in Medically Supervised or Healthy Solutions options attend weekly classes together. 'Core' classes in weight loss meet for 12 weeks and then patients continue in 'Ongoing' classes until they reach their weight goal, enter maintenance or exit the program. These HMR in-clinic weight loss options include the following well-defined treatment components: weekly attendance and mid-week phone call, daily record keeping, greater than or equal to8.4 mJ (>2000 kcal) of physical activity weekly and greater than or equal to35 servings of meal replacements/week; in addition, the Healthy Solutions option includes greater than or equal to35 servings of fruits or vegetables weekly.9 Although the weight loss diet for all obese individuals provides a minimum of 2.2 mJ (520 kcal)/day from shakes, entrees and bars, severely obese patients have average energy intakes of approximately 4.2 mJ (1000 kcal)/day.6

After reaching their goal weight or when weight loss decreases to a minimum, all patients are encouraged to leave the weight-loss phase and enter the Maintenance Program. The Maintenance Program includes weekly attendance and mid-week phone calls, daily record keeping, greater than or equal to8.4 mJ (2000 kcal) of physical activity weekly, greater than or equal to14 servings of meal replacements/week and greater than or equal to35 servings of fruits or vegetables weekly. Patients are encouraged to remain in maintenance for at least 6 months, but many continue maintenance for prolonged periods of time.10 For patients who have completed the 'Core' weight loss classes, these options are available to facilitate further weight loss: Restart Classes that include only previous participants, re-entry into maintenance; and 'Blitzes' that are 3–4 week periods of intensive efforts for weight loss. Many of the patients who completed their initial treatment more than 1 year previously re-enter one of these options. When weights were not available for the weight loss phase, the last observation was carried forward (LOCF) as follows: Study Group, weeks 12 and 26, Completers and 100# Group, week 26.

Follow-up weights were weights measured by clinic staff during a patient visit and none were self-reported weights. Weights were obtained in clinic for patients in the maintenance program, in restart classes or who visited clinic for some other reason and had their weight recorded.

Side effects evaluation: charts were not available for review from two clinics, but progress notes from 100 charts for severely obese patients who lost more than 45 kg at the Kentucky clinic were rigorously reviewed by the first author to assess the frequency and severity of side effects using common terminology criteria.11

Data retrieval: the database was searched for all obese patients with a BMI greater than or equal to30 kg/m2 who enrolled and attended one subsequent class at these three centers over the 8-year period. All patients who had at least 1 week of treatment were included in the 'Study Group' and patients who completed the 12-week core classes were included in the 'Completer Group'. This report will focus on outcomes for severely obese individuals (BMI greater than or equal to40 kg/m2). Data for persons who had documented weight losses of >45.5 kg (greater than or equal to100 lbs) were also analyzed, and are included in the '100-Pound Group.'

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Results

Baseline characteristics

Over 8 years, 3853 patients with obesity (BMI greater than or equal to30 kg/m2) completed 1 week of treatment and 1531 patients with severe obesity met criteria for the 'Study Group' (Figure 1). A total of 1100 patients (72%) completed the 12-week core classes (Completers). Of this 'Completer Group', 268 patients (24.4%) lost >45 kg (greater than or equal to100 lbs, the 100-Pound Group).

Figure 1.
Figure 1 - Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, please contact help@nature.com or the author

Flow diagram for treated obese and severely obese patients.

Full figure and legend (35K)

The average age of participants was similar across study groups with a median age of 44 years (Table 1). While women accounted for 65% of all patients, more men than women lost 100 lb. Initial weights for women and men, respectively, averaged 128 and 159 kg. The average initial BMIs for Study and Completer patients were similar at approx48.4 kg/m2. The average initial BMI for patients losing greater than or equal to100 lb was higher at 52.7 kg/m2.


Weight losses

Weight loss for patients completing the core classes (35.2 kg) represented 25% of initial body weight over an average period of 38.5 weeks (Table 1, Figure 2). This value was significantly higher than for the entire Study Group (28.1 kg, P<0.001). For the 100-Pound Group, 268 patients lost >45.5 kg (100 lb) with weight loss of 62.3 kg or 39.8% of initial body weight, in an average of 57 weeks.

Figure 2.
Figure 2 - Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, please contact help@nature.com or the author

Weight loss of women and men – completers – as % of initial weight. Number of patients provided at 5-week intervals.

Full figure and legend (53K)

Men were more likely to complete the program and lose >45 kg. Men lost significantly more absolute weight (kg) than women in all three groups (P<0.001) with larger percentage weight loss from initial weight for Completer (26.7 vs 23.9% for men vs women, P<0.001) and Study Groups (22.5 vs 18.5%, P<0.001). In contrast, in the 100-Pound Group, women lost a significantly higher percentage body weight than men (41.5 vs 37.5%, P<0.001).

Maintenance of weight loss

All patients were encouraged to enter the Maintenance program after completing the weight loss phase. Only 53% of the entire Study Group enrolled in maintenance, but 72% of the Completers and 87% of the 100-Pound Group enrolled in maintenance (data not shown). Follow-up weights after completing the weight loss program were available as follows: Study Group, 72%; Completers, 86%; and 100-Pound Group, 94%. Patients in the Study Group maintained an average of 20.6 kg or 61% of their weight loss at an average follow-up period of 64 weeks. Patients completing the core program maintained an average of 22.7 kg or 59% of their weight loss at an average of 72 weeks. Patients in the 100-Pound Group maintained an average of 41 kg or 65% of their weight loss for an average of 95 weeks (Table 1). In all three groups, men maintained a significantly higher (P<0.001) percentage of their weight loss over longer periods of follow-up.

Side effects

Data were available for 100 severely obese patients treated in Lexington. Dizziness (35%) and constipation (33%) were the two most common side effects reported by patients. Other reported side effects included: fatigue/weakness (20%), nausea (13%), abdominal discomfort (10%), diarrhea (9%) and headaches (6%). Clinically significant laboratory changes were transient increases in serum uric acid (10%) and transient increases in hepatocellular enzymes (39%). These side effects are considered mild to moderate in severity and only one serious adverse event related to the weight loss program was reported – one person (1%) had a cholecystectomy. Serious adverse events unrelated to the weight loss program were noted in five patients (5%) with four patients undergoing surgery and one person being hospitalized for cellulitis.

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Discussion

Severely obese patients who enrolled in intensive behavioral interventions at three HMR centers and received at least 1 week of treatment lost an average of 28 kg or 20% of their initial body weight. Patients who completed the 12-week core program (Completers) lost an average of 35 kg or 25% of their initial body weight. Approximately 25% of the Completers lost >45 kg (greater than or equal to100 lbs). The 100-Pound Group lost an average of 62 kg or 39% of their initial body weight. Follow-up data were available for 72–94% of patients in these three categories. For the Study Group, follow-up data for 72% of patients at an average of 64 weeks after completion of weight loss indicated a maintenance of 61% of their initial weight loss. Patients who completed the core program were maintaining, at 72 weeks after weight loss, an average of 59% of the weight lost. More complete data – from 94% of patients – were available for the 100-Pound Group; these patients were maintaining an average weight loss of 41 kg, or 65% of their initial weight loss at an average of 95 weeks.

The weight losses currently being reported using an intensive intervention with VLED or LED are greater than previously reported for either VLED or LED.12 In our meta-analysis of weight loss for patients who completed 24 weeks of treatment, weight loss for obese and severely obese individuals treated with LED (10 studies) averaged 11.4% (95% confidence intervals (CI), 8.9–13.9%) while weight loss for persons completing VLED (19 studies) averaged 21.3% (95% CI, 20.1–22.5%) of initial body weight.12

Maintenance of weight loss by these severely obese patients is also greater than reported previously by us13 and summarized from all available reports.14 A major limitation of reports of long-term maintenance of weight loss is the unavailability of follow-up weights on a sizable percentage of patients. In our meta-analysis of long-term maintenance of weight loss, data were only available on 66.3% of patients; some groups reported only on the patients for whom long-term weight data were available, thereby selecting certain patients for reporting.14 In the current analysis, from 1531 consecutively enrolled patients, we had follow-up data available for 72% of the entire Study Group, 86% of the group who completed the 12-week core program and 94% of the 100-Pound Group. In our meta-analysis of weight maintenance for 'completers' of VLED, average values were as follows: 71% of weight loss maintained at 1 year, 43% at 2 years; and 34% at 3 years.14 In the current report for severely obese individuals, maintenance of weight loss for 'Completers' at 72 weeks was 59% and for the 100-Pound group was 65% at 95 weeks.

Side effects associated with these LED were related largely to gastrointestinal complaints15 and the increased risk for gallbladder disease seen with any substantial amount of weight loss.16 We saw no severe side effects and only one of the six hospitalizations (for cholecystectomy) was related to the weight loss intervention. Observed side effects were milder, less frequent and less persistent in this review than noted for patients treated with VLED 15–20 years ago.8

Program costs affect decisions regarding treatment choices. Usually non-surgical weight loss programs are not included in health-care coverage plans. The cost to patients depends on a large number of factors, including geographic location of program, intensity of medical monitoring required and duration of treatment. After the initial evaluation – which may be carried out by the primary care provider and covered by insurance – the major weekly cost is for meal replacements (shakes and entrees). As the average US adult spends slightly more than US$100 weekly for food and beverages consumed at home or outside the home17, 18 and the person with severe obesity undoubtedly spends more, the minimum weekly cost for meal replacements (US$67–85) usually represents a savings. The $20/week for classes represents the only additional cost for persons in the Healthy Solutions program. For persons with diabetes or hypertension on multiple medications participating in the Medically Supervised option, weekly medical monitoring and periodic laboratory monitoring are required. Over the 12-week core, the medically monitored patient would pay about US$360 for this coverage. The cost of ongoing classes would be $20/week for patients in the Healthy Solutions option and an additional $90/month for medical monitoring for patients in the Medically Supervised option.

Response to this lifestyle intervention can be compared to bariatric surgery for severely obese individuals. The Roux-en Y gastric bypass procedure, either open or laparoscopic, is the most effective surgical procedure for the treatment of severe obesity.4 The reported overall perioperative mortality is approx1% and the adverse event rate is approx20%.4, 5 Weight loss at 12 months averages 43.5 kg with maintenance of approx41.5 kg for data reported at 3 years. The weight loss for all patients completing our 12-week core behavioral program (35 kg) is similar to that reported for adjustable gastric banding (30 kg), with a much lower mortality and adverse event rate.4 The cost for gastric bypass surgery and complications, often partially or completely covered by a health-care provider, ranges from US$20 000 to $50 000.19

Physical activity is widely recommended as an adjunct to diet for weight loss and maintenance.20, 21, 22, 23 In our behavioral program, we encourage all participants to achieve a goal of >8.4 mJ (2000 kcal) of physical activity weekly. Average self-reported physical activity during weight loss for severely obese persons who lost >45 kg was approx14 mJ (3350 kcal)/week.6 Our current maintenance experience indicates that patients are maintaining average physical activity levels of 11.3 mJ (2704 kcal)/week.24 It seems likely that severely obese patients who have lost substantial amounts of weight in our intensive behavioral program while maintaining physical activity of greater than or equal to8.4 mJ (2000 kcal)/week for 18 months of treatment in weight loss and maintenance have a higher likelihood of continuing these health-promoting physical activity behaviors than patients who have had bariatric surgery without the benefit of intensive behavioral training related to physical activity.

Long-term maintenance of weight loss is difficult for most individuals.13, 14, 25 Our experience indicates that this is best achieved through ongoing participation in a maintenance program26 or intermittent treatment. Lifestyle behaviors that contribute to successful long-term weight maintenance are as follows: regular physical exercise,23, 27 low fat intakes,28 higher fiber intakes29, 30 and fruit and vegetable consumption.31 The keys to long-term maintenance of weight loss, as taught in our maintenance classes, are as follows: physical activity of >8.4 mJ (2000 kcal)/week, five vegetables or fruits daily and two meal replacements daily to decrease fat and energy intake. Using these strategies, severely obese patients completing our intensive behavioral program with weight losses of 35 kg were maintaining about 59% of this weight loss at 72 weeks. Persons who lost >45 kg were maintaining weight losses of 41 kg (65% of weight loss) at 95 weeks.

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