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Randomized controlled trial of the mend program: a family-based community intervention for childhood obesity

articles
nature publishing group
childhood obesity
Intervention for Childhood Obesity
Paul M. Sacher1, Maria Kolotourou1, Paul M. Chadwick2, Tim J. Cole3, Margaret S. Lawson1,
Alan Lucas1 and Atul Singhal1
The aim of this study was to evaluate the effectiveness of the Mind, Exercise, Nutrition, Do it (MEND) Program, a multicomponent community-based childhood obesity intervention (www.mendcentral.org). One hundred and sixteen obese children (BMI ≥ 98th percentile, UK 1990 reference data) were randomly assigned to intervention or waiting list control (6-month delayed intervention). Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools, followed by a 12-week free family swimming pass. Waist circumference, BMI, body composition, physical activity level, sedentary activities, cardiovascular fitness, and self-esteem were assessed at baseline and at 6 months. Children were followed up 12 months from baseline (0 and 6 months postintervention for the control and intervention group, respectively). Participants in the intervention group had a reduced waist circumference z-score (−0.37; P < 0.0001) and BMI z-score (−0.24; P < 0.0001) at 6 months when compared to the controls. Significant between-group differences were also observed in cardiovascular fitness, physical activity, sedentary behaviors, and self-esteem. Mean attendance for the MEND Program was 86%. At 12 months, children in the intervention group had reduced their waist and BMI z-scores by 0.47 (P < 0.0001) and 0.23 (P < 0.0001), respectively, and benefits in cardiovascular fitness, physical activity levels, and self-esteem were sustained. High-attendance rates suggest that families found this intensive community-based intervention acceptable. Further larger controlled trials are currently underway to confirm the promising findings of this initial trial.
INTRODUCTION
evidence-based intervention (1–3), has been designed to be The recent dramatic rise in prevalence of childhood obesity is delivered in community and primary care settings.
a major public health issue. The extent of the epidemic and its short and long-term effects on physical and psychological METHODS AND PROCEDURES
health, including a potential reduction in life expectancy for The study was conducted between January 2005 and January 2007 at future generations, have made the prevention and treatment of the Medical Research Council Childhood Nutrition Research Centre, childhood obesity a high priority (1).
UCL Institute of Child Health (London, UK) and was approved by the Metropolitan Multi-Centre Research Ethics Committee (Current International recommendations agree that the core elements Control ed Trials ISRCTN 30238779).
of any initiative to address pediatric obesity should involve the whole family and include nutrition education, behavior modi- Participants
fication and promotion of physical activity (1–4). However, Potential subjects were recruited from five UK sites by referrals from available evidence is poor with the main weaknesses of the local health professionals (dieticians, school nurses, and general prac- current literature being small sample sizes, noncomparable titioners), or were self-referred. None of the sites had previously run a interventions, limited generalizability due to delivery in cent- MEND Program. Children were eligible if they were obese (BMI ≥ 98th ers of academic or clinical excellence and other methodologi- percentile, UK 1990 reference data) (7); had no apparent clinical prob- lems, comorbidities, physical disabilities, or learning difficulties, which would interfere with their ability to take part in the program; were aged Pragmatic controlled trials of child obesity treatments between 8 and 12 years; and had at least one parent/carer who was able which address these limitations are clearly needed. The to attend each of the program sessions.
present study aimed to assess the efficacy of a multicom- The MEND Program was delivered at five different sites by separate ponent, community-based childhood obesity intervention teams of health, social, education, and exercise professionals. Sites had their own principal investigator who was present during data col ection. (Mind, Exercise, Nutrition, Do it (MEND) Program). MEND, All measurements were performed in community settings. Informed con- although fulfilling the expert recommendation criteria for an sent was obtained from the parents after provision of written participant 1MRC Childhood Nutrition Research Centre, UCL Institute of Child Health, London, UK; 2Cancer Research, UK Health Behaviour Unit, University College London, London, UK; 3MRC Centre of Epidemiology for Child Health, UCL Institute of Child Health, London, UK. Corr VOLUME 18 SUPPLEMENT 1 | FEBRUARY 2010 | www.obesityjournal.org
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information by post and explanation of the study objectives and methods shown to facilitate safe and effective weight management in obese Study design
Outcome measurements
This randomized control ed trial was designed to assess the effectiveness Data were collected at baseline, 6 and 12 months by two researchers of a 6-month intervention consisting of the 9-week MEND Program (P.M.S., M.K.) who were both dieticians and experienced in working (www.mendcentral.org) followed by a 12-week free-family swim pass. with obese children under the supervision of the local principal inves- All eligible participants were assessed at baseline and then randomly tigators. Because of the delayed intervention, the intensive interaction allocated to start the program immediately (intervention group) or between families and the researchers, and because participants were keen receive the intervention 6 months later (control group).
to discuss their measurements with the research team, blinding to the Children were consented in community venues to determine whether randomization was not possible. To compensate for the lack of blinding, they met the inclusion criteria. Baseline measurements were performed measurements were taken independently by the two researchers.
and randomization was conducted by an independent researcher using a random permuted block design with blocks of size 6. The randomi- Anthropometry
zation schedule was computer generated. Both groups were measured Body weight, height, and waist circumference were measured fol owing again at 6 months and at 12 months from baseline (6 months standardized procedures (12). Weight and height were obtained for both postintervention for the intervention group and immediately postin- children and their mothers, and were subsequently used to calculate BMI. Children were classified as obese if their BMI was >98th percentile for age and gender using the recommended cutoff for treatment or referral (7).
Study intervention
The MEND intervention is an integrated, multicomponent healthy Body composition
lifestyle program based on the principles of nutritional and sports sci- Deuterium dilution was used to measure children’s total body water, and ence plus, from psychology, learning, and social cognitive theories and hence fat mass and fat-free mass were derived (13).
the study of therapeutic processes. The program engages families in the process of weight management by addressing the three components nec- Cardiovascular health
essary for individual-level behavioral change; (i) education (ii) skills Cardiovascular fitness was assessed by the recovery in heart rate 1 min training, and (iii) motivational enhancement (8), while retaining a sys- after a validated 3-min step test, standardized for height (14). Systolic temic understanding of the need to engage multiple, interacting systems and diastolic blood pressure was measured in supine position, on the left of influence within the family context (9). The MEND intervention was arm, with an appropriately sized cuff and an automated blood pressure successful y piloted before the current randomized control ed trial (10). monitor. Three blood pressure measurements were taken after a 10-min The program consisted of 18 sessions delivered over 9 weeks (2-h group sessions held twice weekly in the early evening) by two MEND leaders rest and the average of the last two was used for analysis (15).
and one assistant to groups of 8–15 children and their accompanying parents or carers and siblings in community settings such as sports (rec- Physical activity and inactivity
reation) centers and schools. The sessions comprised an introduction Levels of physical activity and the amount of sedentary behaviors were meeting, 8 sessions focusing on behavior change, 8 sessions providing assessed using a nonvalidated questionnaire adapted from that devel- nutrition education, 16 physical activity sessions and a closing session. oped by Slemenda et al. (16). This was administered by the researchers Following the 9-week programme, free-family access to a local com- to parents and children and included the number and duration of physi- munity swimming pool was made available for a further 12 weeks. The cal education lessons, time spent on different types of vigorous activi- program was delivered using standardized operating procedures. To ties (e.g., sports), and time spent on sedentary activities (e.g., television, ensure standardized delivery across sites, all trainers received 4 days of training and were provided with identical materials: theory and exercise manuals, children’s handouts, program resources, and teaching aids. The Self-esteem
manuals contained detailed methods for the delivery of all sessions.
For self-esteem assessment, children completed the Harter Self- Perception Profile, a widely used assessment tool validated for UK children of this Nutrition sessions. Sessions on nutrition education consisted of healthy eating advice customized for obese children and included healthy eating tips in the form of achievable weekly targets, instructions on the reading and understanding of food and drink labels and other Socioeconomic classification
simple advice designed to produce gradual changes in dietary habits (2). Social class was based on the occupation of the parent providing the Families also took part in a guided supermarket tour and were given main financial support for the family in accordance with the Standard healthy recipes to try at home. In addition, sessions included prepa- Occupational Classification. Ethnic background was obtained from the ration of healthy meals and fruit and vegetable sampling. A “nondiet- parents based on the UK census categorization (18).
ing” philosophy was advocated throughout the intervention; therefore children were discouraged from weighing themselves and encouraged Statistical analysis
to make small lifestyle changes to improve health rather than achieve Based on our pilot study (10), sample size was calculated to detect a 3 cm difference in waist circumference between randomized groups, at 5% significance and 80% power. This required 40 children in each rand- Behavior change sessions. These sessions focused on teaching par- omized group. To account for drop outs, we aimed to recruit 48 children ents and children to apply behavioural techniques such as; stimulus control, goal setting, reinforcement, and response prevention to estab- The primary outcome was change in waist circumference from baseline lish a health-promoting home environment (5,9).
to 6 months, with change in BMI and % body fat as secondary outcomes. Change was analyzed adjusted for the baseline value using linear regression, Exercise sessions. Al sessions included 1 h of exercise for children and adjusted mean change was compared in the two groups. Interactions only. Exercise sessions comprised alternating land and water-based of group by sex were also tested for. Groups were analyzed as randomized. multiskil s activities focusing on noncompetitive group play, previously Change from baseline to 12 months was studied in the intervention arm obeSity | VOLUME 18 SUPPLEMENT 1 | FEBRUARY 2010
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60 Allocated to immediate intervention (52%) 56 Allocated to waiting list (controls) (48%) 6 Never started (10%):–3 Medical reasons–2 Social reasons–1 Unknown Figure 1 Study charts.
Table 1 Descriptive characteristics of the study population at baseline
Data are mean (s.d.) or % (n).
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only. Statistical significance was set at P < 0.05. All analyses were conducted and BMI did not change significantly during the 6 months (P = using SPSS 13.0 for Windows (SPSS, Chicago, IL).
0.3 and 0.8, respectively). Beneficial changes were also noticed for recovery heart rate, physical activity levels, sedentary activi- ties, and global self-esteem There were no significant One hundred and seventeen children were recruited, of whom interactions of the intervention by sex (P = 0.6).
116 were randomized: 60 to the intervention and 56 to the con- shows the results from the start of the intervention trol group (seOf the 60 intervention children, 54 to 6 months for the two randomized groups combined and to started and all 54 completed the intensive phase of the inter- 12 months for the intervention group alone. There were highly vention (9-week MEND Program), while 62% of the 60 were significant reductions in waist circumference and to a lesser seen at 6 months and 83% either at 6 or 12 months. Groups extent BMI in both periods. Improvements at 6 and 12 months were broadly similar at baseline, with a high percentage of were observed for blood pressure, recovery heart rate, physical children from nonwhite ethnic backgrounds and parents in activity level, and global self-estee manual occupations Mean attendance for the pro- There was no difference at baseline between children who gram was 86%, and no adverse effects were reported. In the attended at 6 months and those who did not (P = 0.6).
subsequent 12 weeks, 32% of families used the free swimming DISCUSSION
At 6 months, both waist circumference and BMI were highly Participation in the MEND Program was associated with signif- significantly less in the intervention than the control group, icant improvements in the degree of adiposity as well as indica- adjusted for baseline (−4.1 cm and −1.2 kg/m2, respectively, or tors of cardiovascular health and psychological well- being. To −0.24 and −0.37 z-scores (all P < 0.0001) Similar our knowledge, this is one of the first randomized controlled benefits of the intervention were observed for fat mass but not trials of a complex family-based obesity intervention designed % body fat In the control group waist circumference to be run by nonspecialists in community settings.
Table 2 Comparison of randomized groups at 6 months
Data are mean (s.d.), mean difference (CI) or median (25th quantile, 75th quantile). an may deviate due to missing baseline data, CI: 95% confidence interval.
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Table 3 Within subject changes at 6 and 12 months from start of intervention
Data are mean (CI), CI: 95% confidence interval.
aIncludes children from both groups measured before and after the intervention (i.e., baseline and 6 months for the intervention group, 6 and 12 months for controls). bIncludes children from intervention group only.
The study examined the effects of the MEND intervention BMI was significantly reduced in the intervention group on three indicators of adiposity: waist circumference, BMI, and compared to the controls, with a mean adjusted reduction of body composition. Waist circumference was designated as the 1.2 kg/ m2 for BMI and 0.24 for BMI z-score. This matches or primary outcome measure, an unusual choice in child obesity exceeds results from other treatment trials (30–33). In another intervention studies. The reason for this was that the MEND study (34), BMI at 6 months fell by 3.1 kg/m2 compared to con- intervention targets both diet and physical activity, aiming to trol, but the sample was more obese and mean BMI in the con- reduce body fat and at the same time increase lean body mass. trols increased by 1 kg/m2. By contrast the controls in our study As BMI does not distinguish between fat and lean mass, it would remained stable (35). The observed reduction of 0.24 is four times be possible for a rise in lean to mask a fall in fat. Waist circum- the average decrease of 0.06 observed for lifestyle interventions ference is not susceptible to this effect, as it does not depend in the most recent Cochrane review on childhood obesity (4). on lean mass (19). We felt that this advantage outweighed the This analysis included four well-designed interventions in chil- known disadvantages of waist circumference—greater meas- dren aged up to 12 years old. In our study, the changes in favor of urement error and variability over time compared to BMI.
the intervention group occurred in the absence of a BMI z-score Waist circumference decreased by 4.1 cm in children in the increase that one would expect to see in the controls (35).
intervention group compared to controls, comparing favora- Body composition was a third measure of the intervention’s bly with the results reported by two other randomized studies effect on adiposity. We found only small changes in body com- of multidisciplinary lifestyle intervention for pediatric obesity position, with a trend toward reduced fat mass in the interven- (20,21) and three studies on the effects of pharmaceutical man- tion group after adjusting for baseline It is possible that agement of obesity (22–24). In adults, a large waist circumfer- greater changes occurred in body fat distribution (as shown by ence has been shown to increase mortality risk by 20% (25) and the reduction in waist circumference) than in overall body com- its reduction has been associated with significant health benefits position, which may need more time to show itself. This is sup- (26,27). The clinical significance of reducing waist circumference ported by Hunt et al., who reported that BMI z-score needs to in children is currently unknown, but its measurement is being fall by at least 0.5 for definite % fat reduction, and represents sub- encouraged to better assess effectiveness of obesity treatment cutaneous fat rather than visceral fat loss (36). However, visceral programs (19,28), given that excess abdominal fat in children is fat—which is better predicted by waist circumference (37)—is associated with several cardiovascular disease risk factors (29).
the tissue linked to cardiovascular disease risk in children (38).
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Physical activity and sedentary behaviors are an essential of the intervention protocol for consistent delivery across set- focus for a successful obesity intervention. In our study, after tings, and the use of multiple health markers to gain a clear the intervention, children were more physically active, reduced picture of the intervention effects.
their sedentary activities and were fitter as indicated by the This study has several limitations. First, there was a lack of blind- reduction in recovery heart rate following the 3-min step test ing for measurement of outcomes as a consequence of the waiting There was also a trend for blood pressure reduction list control study design. To minimize this bias, more subjective which was nonsignificant with the exception of unadjusted measurements (e.g., waist circumference) were independently diastolic blood pressure These beneficial changes performed by two researchers (P.S., M.K.) and al measurements were largely sustained at 12 months and may be were overseen by the principal investigator at each site.
linked to an improved cardiovascular disease risk profile (39).
As with all intervention studies, selective drop out may have Action to improve the physical health of obese children has influenced the results. However, 83% of children in the inter- been tempered by fears that pediatric weight-management vention group were seen either at 6 or at 12 months, and of interventions may have adverse psychological consequences these, all who missed the 6-month visit reduced or maintained (40). However, scores on the measure of global self-esteem sig- their BMI and waist circumference z-scores from baseline to 12 nificantly increased during the intervention suggest- months. This indicates that the high-drop out rate at 6 months ing that participation was associated with psychological benefit was most likely due to logistical factors, as there was only one rather than harm. These results add to a small but growing opportunity for measurement at each community site.
body of literature indicating that responsibly conducted pedi- A third limitation was the relatively short follow-up atric weight management may improve the emotional health of (12 months from baseline for the intervention group only), which limits conclusions about the long-term effects of the Sustainability of results is crucial in assessing weight- intervention. This is a limitation of all similar intervention management programs. In this study, the benefits were sus- studies to date. To address these limitations a second UK rand- tained up to 9 months after participants had completed the omized controlled trial is currently in progress.
intensive phase of the intervention (12 months from base- In conclusion, participation in the MEND Program was line) More precisely, waist circumference and BMI effective in reducing adiposity in children and effects were sus- z-scores decreased by 0.47 and 0.23, respectively. Most of the tained 9 months after the intensive part of the intervention. secondary outcomes also improved indicating longer-term Importantly, the program is one of the few pediatric obesity improvements in fitness and lifestyle (as indicated by the interventions which conforms to expert recommendations and reductions in systolic blood pressure, recovery heart rate, and is deliverable in a primary care setting. These results suggest physical activity levels) as well as improved psychological well- that the MEND Program is a promising intervention to help being (as indicated by the increase in self-esteem). The poor address the rising obesity problem in children. Further research use of the family swimming pass suggests that the effects of the is ongoing to measure the effectiveness of the program when intervention were largely due to the 9-week MEND Program delivered on a larger scale using methods that will address the (intensive phase) rather than provision of free access to a phys- ical activity venue. These observations compare favorably to longer-term outcomes reported by other interventions (4).
ACKNOWLEDGMENTS
Financial and nonfinancial support (e.g., staff and venues) were provided
by the following UK organizations: National Institute for Health Research,
Strengths and limitations
Sainsbury’s Supermarkets Ltd., Bromley Mytime, Bromley Primary Care A key strength of the MEND Program was its acceptability Trust (PCT), Great Ormond Street Hospital for Children NHS Trust, London to families—all the children who started completed it. Also, Borough of Lewisham, MEND Central Ltd., New Cross Gate New Deal for the mean 86% attendance was similar to our pilot study and Communities, Parkwood Leisure, Southwark PCT, The Lewisham Hospital NHS Trust, UCL Institute of Child Health, and Waveney PCT. T.J.C., A.L., higher than reported for other childhood obesity interventions and A.S. are funded by the MRC. The MEND research team would like to (42,43). Therefore, the intensive program was acceptable and thank all the children and parents who participated in this trial.
Standardization of the MEND Program al owed the interven- DISCLOSURE
tion to be delivered by community practitioners who had no P.M.S. is currently employed as a Senior Research Fellow at the UCL Institute of Child Health as well as part-time Chief Research and previous expertise in the management of pediatric obesity and Development Officer at MEND Central. P.M.S.’s employment at MEND had never delivered a MEND Program. Physical, behavioral, and Central commenced after completion of this trial. M.K. was employed as a emotional outcomes were similar to those obtained when the Research Assistant at the UCL Institute of Child Health and is now employed intervention was delivered by specialists (Pediatric Dietician, part-time at MEND Central. P.C. was employed as a Clinical and Health Psychologist at Cancer Research UK Health Behaviour Research Centre, Consultant Clinical Psychologist, and Physiotherapist) (10). Department of Epidemiology and Public Health, UCL at the time that the Maintenance of outcomes in the face of such substantial dilu- research was conducted and is currently employed part-time as Clinical tion of expertise in the delivery team, suggests that the MEND Director at MEND Central. T.J.C. and M.S.L. have no conflict of interest. Program can be delivered effectively in a primary care setting.
MEND Central as a social enterprise has committed to return a proportion of its future revenue to the UCL Institute of Child Health so that research In terms of the study design, some other advantages included on child obesity can be further supported. Apart from a commitment to the multicentre delivery of the intervention, the standardization using such funds to forward public health research into obesity, A.L. has obeSity | VOLUME 18 SUPPLEMENT 1 | FEBRUARY 2010
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no other conflict of interest. A.S. supervised the research. Apart from the 23. Klein DJ, Cottingham EM, Sorter M, Barton BA, Morrison JA. funds that will be derived from MEND to support research into child obesity A randomized, double-blind, placebo-controlled trial of metformin (see above), A.S. has no other conflict of interest.
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