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Health-related quality of life in WHO Class II–III obese men losing weight with very-low-energy diet and behaviour modification: a randomised clinical trial

Abstract

OBJECTIVE: To study health-related quality of life responses to marked weight loss in WHO Class II–III (body mass index (BMI) ≥35 kg/m2) obese men.

DESIGN: An 8 month randomised clinical trial with a 4 month weight loss programme (10 weeks on a very-low-energy diet (VLED) and 17 behaviour modification visits) in the treatment group and no intervention in the control group.

SUBJECTS: Nineteen men (mean age 45.9 y, mean BMI 39.3 kg/m2) in the treatment group and 19 men (47.2 y, 39.4 kg/m2) in the control group.

MEASUREMENTS: Weight and questionnaires measuring health-related quality of life (RAND 36-Item Health Survey 1.0 and obesity-related psychosocial problems scale).

RESULTS: In the treatment group, the mean (s.d.) weight loss was 17.0 (7.4)% at the end of the 4 month therapy. At the end of follow-up, nearly 6 months after the end of VLED in the treatment group, the average maintained weight loss was 13.9 (7.8)% of baseline weight. The control group was weight stable throughout the study. During treatment, there was only transient improvement in general health, bodily pain, mental health, emotional role functioning and vitality (all increases in the scores were not statistically significant). Improvements in physical functioning, social functioning and obesity-related psychosocial problems were maintained until the end of follow-up. The treatment group also reported improvement in perceived health in the past year. There was only minor fluctuation in questionnaire scores in the control group.

CONCLUSION: The short-term and maintained health-related quality of life effects of weight loss may differ. Marked weight loss in WHO Class II–III obese men leads to improvements in physical functioning, social functioning, obesity-related psychosocial problems, and perceived health; these improvements were maintained at 4 month post-intervention follow-up.

Introduction

Obesity with its co-morbidities1,2 is potentially associated with a poor physical, mental and social health-related quality of life (HRQOL). In population-based crosssectional studies, an increasing degree of obesity has been associated with compromised quality of life, especially physical functioning.3,4,5,6,7,8,9,10,11

Compared with the obese not seeking treatment, obese individuals applying for treatment in weight loss programmes have an even more impaired HRQOL.12,13,14,15,16,17 This is probably due to obesity-specific problems and a high prevalence of co-morbidity. The marked weight loss achieved by surgical techniques has been associated with improvements in deteriorated HRQOL.18,19,20,21,22,23,24 Two short-term randomised weight loss trials with lifestyle intervention have shown improvements in HRQOL.25,26 The duration of these studies was only 12–13 weeks and there was no follow-up after the intervention; the longer-term effects of non-surgical weight loss interventions on HRQOL have not been studied.

Combining a very-low-energy diet (VLED) with behaviour modification produces rapid and marked initial weight loss,27 which may improve long-term maintenance.28 The aim of this trial was to study the short-term and maintained effects of marked weight loss on HRQOL in a clinically representative population of WHO Class II–III obese men.

Methods

Study design

This was an 8 month open, prospective, single-centre, randomised and controlled trial. Obese men were randomly assigned to two parallel groups: 19 men in the treatment group (TG) and 19 men in the control group (CG). Randomisation was carried out using a computer-generated table of random numbers. Blocks of four were used in order to assure equal distribution of subjects into two groups. Age and BMI stratified randomisation. A sample size calculation was not performed.

The TG took part in a 4 month weight loss programme, after which there was a 4-month follow-up period with no maintenance programme. The men in the CG were asked to maintain their current lifestyle without any attempts to lose weight; they took part in the weight loss programme immediately after serving as controls in this study. Figure 1 presents the study design.

Figure 1
figure1

Study design and disposition of subjects.

Subjects

WHO Class II–III obese Finnish men aged 18–60 y and with a body mass index (BMI) ≥35 kg/m2 were recruited by a newspaper advertisement in November 1999. We first screened the candidates by telephone and excluded subjects by predetermined criteria: type 1 diabetes mellitus, over 5 y since the diagnosis of type 2 diabetes mellitus, excessive intake of alcohol or other substances, or any contraindication to a VLED.27 The results reported here are part of a larger study primarily investigating the effects of weight loss on sex-steroid metabolism and sexual functions. Therefore, we also excluded single men and men with primary testicular failure or prostate cancer (Figure 1).

By December 1999, the eligible subjects visited our obesity clinic at the Peijas Hospital, in Vantaa, Finland. We re-checked the entry and exclusion criteria at this screening visit, including a medical history and a physical examination.

Weight loss programme

In January 2000 the TG men started the 4 month weight loss programme. They attended 17 weekly 1.5 h behaviour modification group sessions led by a clinical nutritionist and a nurse. The behaviour modification programme is based on the LEARN Programme for Weight Control.29 The core elements of behaviour modification are goal setting, nutrition (decrease in fat intake and increase in complex carbohydrates and fibre intake), exercise (mainly lifestyle exercise), self-monitoring, stimulus control, problem solving, cognitive restructuring, and relapse prevention. The TG men received VLED (Nutrifast®, Leiras, Helsinki, Finland) as their only diet for 10 weeks (study weeks 1–11). The diet provided 52 g of protein, 64 g of carbohydrates, 8 g of fat, vitamins, trace elements and minerals daily with an energy intake of 2200 kJ/day. A small amount of low energy vegetables was allowed. A normal diet was gradually introduced during week 12. All subjects received the physical examination and treatment free of charge.

Assessments

Body weight and HRQOL were measured in both groups at week 0 (baseline), at week 11 (last week with VLED in the TG), at week 17 (last group visit for the TG), and 4 months later at week 32 (end of the study). During measurements of height and weight the subjects wore indoor clothing with no shoes on. BMI was calculated (weight in kilograms divided by the square of height in metres). The men completed the quality of life questionnaires and we checked the questionnaires in order to avoid missing data.

The RAND 36-Item Health Survey 1.030 (RAND-36) served as a generic HRQOL measurement. It is identical to the MOS SF-36,31 only the scoring of the general health and bodily pain scales differing slightly. RAND-36 covers four separate scales on the physical HRQOL: physical functioning (10 items, three-point scale); role functioning/physical (four items, two-point scale); bodily pain (two items each, five and six-point scale); and general health (five items, five-point scale). There are three scales on the mental HRQOL: mental health (five items, six-point scale); role functioning/emotional (three items, two-point scale); and vitality (four items, six-point scale). One scale covers the social HRQOL: social functioning (two items, five-point scale). Each scale has a score range from 0 (maximal impairment) to 100 (no impairment). Also included is a scale on health change in the past year (five-point scale from much worse to much better). We used the Finnish version of RAND-36 with the population reference values available.32

The obesity-specific OP-scale3 measured the obesity-related psychosocial problems in everyday life (eight items, four-point scale). The questionnaire asks how bothered the subject is by his/her obesity as regards private gatherings, going to restaurants or community activities, holidays away from home, trying on and buying clothes, bathing in public places, and in intimate relations with a partner. The OP-scale has a score range from 0 (no impairment) to 100 (maximal impairment). The psychometric properties of the OP-scale among a Swedish population of obese subjects have been published.3 The scale showed moderate correlation to a variety of other psychosocial measures; this indicates that OP-scale measures separate aspects of psychosocial functioning. In collaboration with the developers we adapted the original Swedish OP-scale to Finnish, using the procedures of forward and backward translation and pilot-testing on obese individuals who also participated in a debriefing interview. The psychometric properties of the Finnish version of the OP-scale will be published separately.

Statistics

All analyses were done using SPSS 10.0 for Windows.33 We analysed all prospective data in the intention-to-treat (ITT) population with the last measure carried forward, and in the completers' population with the full data available. We used the general linear modelling, repeated measure procedure with one factor for comparisons between subjects (treatment or control group) and one factor for comparisons within subjects (time with four levels); see the tables and figures for results. We defined the comparisons within subjects using the repeated factor to compare each follow-up point to the baseline, in this case the end of the VLED vs baseline, the end of group therapy vs baseline, the end of follow-up vs baseline; see text for results. We analysed the correlation between changes in weight and HRQOL-data using Pearson's bivariate correlation with a two-tailed test of significance. We considered the P-value <0.05 statistically significant. We report all results in the ITT-population; the results were similar in the completer population.

Ethical issues

The Peijas Hospital Ethical Committee approved the study protocol and the informed consent form. All subjects received written and oral information before signing the consent form. We treated all study subjects according to The Helsinki Declaration.34

Results

Subjects

We screened a total of 72 men and excluded 34 (47%) subjects by predetermined criteria: age (n=11), no interest in entering study (7), BMI (5), no intimate relationship (4), psychiatric disorder (3), type 2 diabetes duration>5 y (1), primary testicular failure (1), carcinoma of the prostate (1), other (1). The remaining 38 subjects were randomised into two groups: 19 in the TG and 19 in the CG. The dropout rates during the study were 16% (n=3) and 11% (n=2) in the treatment and control groups, respectively (Figure 1).

Table 1 presents the baseline data of the randomised subjects. The two groups were similar with respect to age, education, smoking and alcohol consumption. However, the men in the CG had more chronic diseases (mean (s.d.) 1.4 (0.1) and 0.9 (0.9) in the CG and TG, respectively). More men in the CG were employed, and married or living together with their partner. A t-test was performed in questionnaire item scores: there was a statistically significant difference between the groups in the scores of physical role functioning (P=0.034); all other differences were statistically insignificant.

Table 1 The baseline characteristics of the randomised men

Weight reduction

The men in the TG lost weight rapidly with a VLED as the only diet for 10 weeks. In the ITT population, weight reduction in the TG was 17.0 (7.4)% (mean (s.d.)) of baseline weight at the end of VLED, 17.0 (7.4)% at the last behaviour modification visit, and 13.9 (7.8)% at the end of the follow-up period. After treatment, during the 4 month follow-up period there was some weight regain (3.8 (3.9) kg) in the TG. The mean weight change from baseline to the end of follow-up was −17.3 (10.2) kg and +0.2 (4.8) kg in the TG and CG, respectively. The CG men remained weight-stable throughout the study (Table 2).

Table 2 The weight and BMI in the treatment and control groups during the study (ITT-population)

HRQOL at baseline

In the study population, the scores of the RAND-36 were markedly lower than the scores of men aged 45–49 y in the general Finnish population. The greatest disparities were seen in the scores for physical functioning, physical role functioning and vitality. The scores were close to the scores in the general population (including both sexes) with chronic illness (Figure 2).

Figure 2
figure2

The mean scores of RAND-36 in the study population (n=38) compared with the data form the general Finnish population.

There was some association between the mental HRQOL items in the RAND-36 and the OP-scale. The OP-scale score correlated with the RAND-36 scores on mental health (r=−0.378, P=0.021), vitality (r=−0.456, P=0.005), and social functioning (r=−0.520, P=0.001).

Physical HRQOL

In the TG, during the rapid weight loss with the VLED, all the scores measuring physical HRQOL increased: physical functioning (P=0.002, within-subject contrast relative to baseline, group×time interaction) and general health (P=0.013) reached statistical significance (Figure 3). However, the improvement in general health was only transient, since by the end of group therapy (6 weeks after the end of the VLED), there were no significant differences between the groups. In the TG, the improvement in bodily pain peaked at the end of group therapy (P=0.034), but this improvement had diminished by the end of follow-up. Although the scores on physical role functioning increased in the TG, the respective scores in the CG fluctuated, and there was no significant difference between the groups during the study. The scores on physical functioning remained significantly higher until the end of follow-up with an effect size 0.7 (Table 3).

Figure 3
figure3

The mean change in the scores of the scales measuring physical quality of life (RAND-36) in the treatment and control groups during the study (ITT-population). Treatment group (diamond); control group (square); BL, baseline; W11, mean change at week 11; W17, mean change at week 17; and W32, mean change at week 32. P-values are for test of treatment effect (group×time interaction) in general linear modelling, repeated measure procedure. P(adj)-values include adjusting for the number of chronic diseases at baseline. *P<0.05; **P<0.01; and ***P<0.001; these P-values are for the comparisons between groups using the repeated factor to compare each follow-up point to baseline.

Table 3 The effect sizes of main results in the treatment group at study weeks 11, 17 and 32

Mental and social HRQOL

Though the scores on mental health and emotional role functioning increased slightly with moderate effect size in the TG during the VLED, the scores returned to baseline levels by the end of group therapy (Figure 4). This transient increase in scores was not statistically significant. The scores on vitality and social functioning increased during the VLED (P=0.032 and 0.009, respectively, within-subject contrast relative to baseline, group×time interaction). The vitality scores started to decrease after VLED and there was no statistically significant difference between groups thereafter. The between group difference between the change in social functioning scores was evident until the end of the study (P=0.030).

Figure 4
figure4

The mean change in the scores of the scales measuring mental and social quality of life (RAND-36) in the treatment and control groups during the study (ITT-population). Treatment group (diamond); control group (square); BL, baseline; W11, mean change at week 11; W17, mean change at week 17; and W32, mean change at week 32. P-values are for test of treatment effect (group×time interaction) in general linear modelling, repeated measure procedure. *P<0.05 and **P<0.01; these P-values are for the comparisons between groups using the repeated factor to compare each follow-up point to baseline.

Obesity-related psychosocial problems

In the treatment group, the scores on the OP-scale decreased during the VLED (Figure 5). This reduction in obesity-related psychosocial problems in everyday life in the treatment group peaked at the end of group therapy (P=0.013 for within-subject contrast relative to baseline, group×time interaction) and was maintained until the end of follow-up (P=0.004). In the control group, the scores on the OP-scale remained stable throughout the study.

Figure 5
figure5

The mean change in the scores of the scale measuring obesity-related psychosocial problems in everyday life (OP-scale) in the treatment and control groups during the study (ITT-population). Treatment group (diamond); control group (square); BL, baseline; W11, mean change at week 11; W17, mean change at week 17; and W32, mean change at week 32. P-values are for test of treatment effect (group×time interaction) in general linear modelling, repeated measure procedure. *P<0.05 and **P<0.01; these P-values are for the comparisons between groups using the repeated factor to compare each follow-up point to baseline.

Health change in the past year

The men in the TG also reported markedly improved health change in the past year. These changes were already evident at the end of the VLED and persisted until the end of follow-up. In the TG, the mean change from baseline was 23.6 (6.8) at the end of VLED, 28.9 (6.7) at the end of group therapy, and 25.0 (6.3) at the end of follow-up. The respective changes in the CG were −3.9 (4.4), −1.3 (4.5), and −1.4 (6.2) (P<0.001 for test of treatment effect (group×time interaction), repeated measure procedure). In the TG, 5.3% reported worse health, 21.1% unchanged and 73.7% improved health in the past year. The respective proportions in the CG were 27.8, 44.4 and 27.8% (Pearson chi-square test, P=0.016). This end point reached the highest effect size, peaking at 2.0 at the end of therapy (Table 3).

HRQOL in relation to weight change

In the analysis of pooled data from the treatment and control groups, weight change during the study was inversely correlated with the change in the scores on physical functioning (r=−0.502, P=0.001) and perceived health change in the past year (r=−0.633, P<0.001). The decrease in scores on obesity-related psychosocial problems in everyday life correlated with weight change (r=0.635, P<0.001). Weight change did not correlate with the RAND-36 score on social functioning (r=−0.227, P=0.117) or vitality (r=−0.263, P=0.115).

Discussion

We conducted a randomised clinical trial among WHO Class II-III obese men showing weight loss averaging 17% at the end of 4 months of treatment and 14% at the end of nearly 6 months in weight maintenance phase. Physical functioning, social functioning, obesity-related psychosocial problems, and subjective perception of health all improved, and these improvements were maintained during the 4 month follow-up after treatment. Only transient improvement in bodily pain, general health and the mental HRQOL scales appeared during treatment with the VLED and behaviour modification. Adjusting for the number of chronic diseases at baseline affected the significance of bodily pain and general health responses; adjusted weight loss seemed to improve bodily pain but not general health. At the end of the study, 74% of men in the TG reported improvement in the perceived health during the past year. The improvements in scores were well above the suggested five-point minimal clinically important difference on a 100-point scale.35

There are only two previous randomised trials on the effects of weight loss on HRQOL, both with a conservative weight loss method. Fontaine et al26 had a 13-week trial comparing lifestyle physical activity with traditional aerobic physical activity showing improvement in physical functioning, physical role functioning, general health, vitality, social functioning and mental health, but no between-group differences in weight loss or HRQOL responses. Rippe et al25 randomised 80 women into a 12-week weight loss group and a control group. The intervention group showed increased physical functioning, vitality and mental health. These trials were very short in duration, had no follow-up at the weight maintenance phase after intervention, and did not include any obesity-specific HRQOL-questionnaires.

Observational studies have consistently shown an association between obesity and impaired physical functioning at BMI above 27–30 kg/m2.3,4,5,6,7,8,9,10,11 Physical functioning has improved in previous weight loss studies regardless of weight loss method,19,20,21,22,23,24,25,26 and our data showing maintained improvement in physical functioning accord with this evidence. A synthesis of observational and intervention data suggests that obesity is detrimental to physical functioning, but that poor physical functioning can be reversed with weight loss.

The association between obesity and mental functioning in observational studies has not been clear.36 Impairment in mental well-being has been shown among morbidly obese individuals,3 and obese individuals suffering from co-morbidity,10 binge-eating37 or pain.13 The positive changes in mental HRQOL have been related to the magnitude of weight loss and the duration of follow-up, with some tendency for the scores to return towards baseline levels in subjects with less than a 20 kg weight loss at a 2 y follow-up.18 The two previous randomised trials by Rippe et al25 and Fontaine et al26 showed improvement on mental health and vitality among obese women losing weight. In our study among men, there were transient improvements in the mental health scales of RAND-36 during treatment. This pattern of response has to be confirmed in studies with large samples, and the ideal setting of equal distribution of sexes would enable reporting of gender differences in response to treatment.

A few obesity-specific quality of life questionnaires addressing psychosocial functioning have been developed,3,14,17 although no randomised intervention trials have previously been published. Again, the strongest evidence available regarding the effects of weight loss has been produced among surgically treated morbidly obese patients. The Swedish Obese Subjects study18 reported a dramatic improvement in obesity-related psychosocial problems in everyday life as measured by the OP-scale: 2 y after the operation the scores were reduced by 63% in men and 57% in women.

Because the men in this study were WHO Class II–III obese and the prevalence of co-morbidity was high, this population can be regarded as representative of men entering treatment in obesity clinics. Note, that only one and three men had diabetes in the TG and CG, respectively. The drop-out rate (16% in the treatment group and 11% in the control group) in our study was small compared to many other weight loss studies.14,19,22,25,38 Therefore, despite the small sample size, the effects were similar in the completer and ITT populations, further validating our results. However, there are limitations to this study. Small sample size led to potential bias owing to the uneven distribution of some variables (especially co-morbidity), possibly affecting HRQOL. Furthermore, small sample size might not reveal minor yet important effects. On the other hand, repeated measurement of multiple outcomes poses the possibility of statistically significant differences without true treatment effect. Therefore, the less markedly significant results (P-values 0.05–0.10) merely indicate possible treatment effects and need to be explored in further studies with larger populations. It also needs to be noted that short-term effects on HRQOL in weight loss studies must be interpreted with caution. More information is needed on the HRQOL effects of long-term maintained weight loss.

We conclude that WHO Class II–III obese men motivated to lose weight by combining a VLED and behaviour modification can achieve maintained improvements in HRQOL. Some observational evidence suggests that intentional weight loss increases longevity in high-risk populations;39,40 at least the metabolic benefits of weight reduction are well established.41 Proven beneficial effects on the quality of life would further support attempts to lose weight if obese.

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Acknowledgements

We wish to thank clinical nutritionist Leena Virtanen and head nurse Pertti Sopanen for their skillful treatment of the study groups. We gratefully acknowledge the VLED (Nutrifast®) provided free of charge by Leiras Finland. This work was supported by a grant from the Yrjö Jahnsson Foundation.

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Correspondence to J Kaukua.

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Kaukua, J., Pekkarinen, T., Sane, T. et al. Health-related quality of life in WHO Class II–III obese men losing weight with very-low-energy diet and behaviour modification: a randomised clinical trial. Int J Obes 26, 487–495 (2002). https://doi.org/10.1038/sj.ijo.0801953

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Keywords

  • obesity
  • weight loss
  • very-low-energy diet
  • behaviour modification
  • quality of life

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