Prevention of Childhood Obesity in Child Health Services: Follow-Up of the PRIMROSE Trial

Abstract

Background:

Childhood obesity is an urgent public health concern, and there's a need for long-term, high-quality, primary prevention trials targeting parents of young children. The aim of the current study was to evaluate the long-term effect of a parental support program based on motivational interviewing (MI).

Methods:

A cluster randomized controlled trial was carried out in eight Swedish counties. Participating families (N = 1355) were enrolled when the child was 9 months old, and participated in nine sessions during ∼39 months. The aim was to pomote healthy food and physical activity (PA) habits using MI and principles from cognitive behavioral therapy. Nurses in Swedish child health services delivered the intervention, and the control group received usual healthcare. The current study was a 1-year follow-up of effects on children's weight-related measures. Regression analyses were conducted using generalized estimating equations, including analyses to investigate potential parental moderators of the effect.

Results:

There were no statistically significant intervention effects at follow-up [BMI difference = −0.13, p = 0.29, overweight relative risk (RR) = 0.96, p = 0.78, obesity RR = 0.57, p = 0.20]. Maternal waist circumference and unhealthy eating and paternal PA moderated the effect, but effects were small and failed to reach statistical significance after correction for multiple comparisons.

Conclusions:

A parent-focused primary prevention intervention based on MI delivered within child health services did not result in effects at 1-year follow-up. The results were in line with those obtained at post-assessment and indicated no late onset of effect. Further studies exploring individual and contextual factors influencing the outcome are called for.

Introduction

According to the World Health Organization,¹ childhood obesity is one of the most serious health challenges of the 21st century. The prevalence of overweight and obesity among children has increased dramatically between 1980 and 2013.² Current national weight data for Swedish children younger than the age of 5 years are not available, but according to a recent regional study, the prevalence of overweight among 4-year olds was 10.7% among boys and 13.2% among girls,³ and higher prevalence among children living in areas with low-income levels has been observed.^3,4

The causes of childhood overweight and obesity are complex and involve multiple factors, such as genetics, fetal and postnatal environment, nutrition, feeding behaviors, lifestyle, and socioeconomic status.^5,6 Parents are considered to be important role models in terms of inducing healthy eating and physical activity (PA) behaviors.^7,8 Studies show consistent findings regarding the associations between parent and child food intake, the importance of home availability and accessibility of healthy and unhealthy foods, and the positive effect of parental encouragement and restriction.⁸

Childhood overweight and obesity are associated with a wide range of social, psychological, and physical health consequences.^5,9 In addition, it increases the risk of overweight and obesity in adulthood^10,11 and consequently the risk of obesity-related adult morbidity.^12,13 Despite many ambitious attempts by leading researchers, only modest and short-term weight-related treatment effects for adult and childhood obesity interventions have been found.^14–16 This, combined with the physical and psychological comorbidities frequently associated with childhood obesity, calls for preventive efforts.¹⁵

Reviews and meta-analyses of interventions with the aim of prevention show inconsistent findings, with most of them conducted in educational settings with school-age children.^17–20 A systematic review and meta-analysis, including 90 randomized controlled trials (RCTs) with weight-related outcomes, showed no effect for children aged 0–5 years.¹⁷ According to another systematic review of RCTs targeting children younger than the age of 5 years, no study has been able to demonstrate an effect on adiposity.²¹ A recent meta-analysis of 50 RCTs aimed at preventing/reducing early childhood obesity with programs involving parents showed a significant, yet small, combined effect size in terms of weight-related measures, that was not sustained at long-term follow-up (more than 3 months).¹⁶

The universal prevention strategy, targeting the entire population and not a specific subgroup with heightened risk of disease²² or primary prevention, which refers to interventions that aim to prevent the occurrence of disease before it develops,²³ has often been regarded as most desirable, considering the reduced risk of stigma and the epidemic proportion of childhood obesity.²⁴ To our knowledge, only one systematic review has focused on universal/primary prevention of childhood obesity.²⁴ The review by Haynos and O'Donohue²⁴ identified 29 RCTs, including weight-related outcomes, but only two were directed toward preschool children. One of these trials²⁵ showed mixed findings (positive results for girls only) and the other²⁶ showed no effects. Both interventions targeted PA and were delivered at preschools,^25,26 and one of the studies also included parental education.²⁶

There has been a call for prevention studies that include follow-up measures, and target parents of young children in settings other than schools/preschools (e.g., primary care).^17,21,27,28 The most recent Cochrane report on this topic¹⁹ concluded that interventions, including parent support for encouraging children's healthy eating and PA, showed promise, yet, more rigorous research is needed, specifically of interventions targeting young children, with follow-up of at least 1 year.¹⁹ There have been examples of delayed effects in prevention studies,^29–31 indicating the importance of long-term follow-up measures.

Motivational interviewing (MI) is a collaborative psychological treatment, which aims to resolve the client's ambivalence and increase motivation for behavior change.³² MI has mainly been evaluated within the field of substance abuse, with generally favorable results.^33,34 A systematic review of studies using MI components in the treatment of childhood obesity (ages 2–11) found six eligible studies, of which half had significant effects on BMI. The authors concluded that more studies are needed within this field.³⁵ MI has been previously suggested to be a suitable method for the prevention of childhood obesity.³⁶ However, empirical studies investigating the efficacy of MI within this context have so far shown weak or no effect in children and their parents.^37–40 Nevertheless, it has been suggested that more rigorous studies, with more extensive practitioner training and higher fidelity should be evaluated in future studies.^39,40

In a meta-analysis investigating potential moderators of weight-related outcomes in treatment and prevention interventions targeting young children, it was concluded that child age, gender, ethnicity, and baseline weight of child or parent were not related to the outcome.¹⁶ Another meta-analysis showed no moderating effect for participant ethnicity or risk status (selected or universal trials) and stronger effects for children and adolescents relative to preadolescents and for interventions directed toward females only.²⁰ However, there is a lack of studies examining moderators of effects in childhood obesity prevention trials, especially in terms of parental characteristics.^17,18,41 Prior research has shown that children of parents with overweight/obesity, lower levels of education, and poor dietary and PA habits are at an elevated risk of developing childhood obesity.^7,8,42,43 We hypothesized that parents displaying any of these characteristics would benefit more from a preventive intervention than parents without these features. An RCT evaluating MI to prevent and manage childhood obesity observed greater intervention effects among families with lower income, and the authors suggest that these families had more room for improvement since the children in these families had higher BMI at baseline.³⁹

The current study is a follow-up of the PRIMROSE trial, a cluster RCT with the aim of universal and primary prevention of childhood obesity, conducted at Swedish child health care centers (CHCs) between 2008 and 2015.^44,45 The results at post-intervention, when the children were 4 years old, showed some evidence of healthier food habits among children and mothers, but no effect on children's or mothers' BMI, prevalence of overweight, or PA habits.⁴⁵

In the present study, our primary aim was to investigate childrens' weight-related outcomes at 1-year follow-up, when they had reached 5 years of age. Our secondary aim was to analyze the potential moderating effects of baseline factors in terms of parents' weight status, BMI, waist circumference (WC), eating, PA, and educational level on children's weight status and BMI at follow-up.

Methods

Details about the study design, methodology, and content of the intervention have been previously published in the protocol of the PRIMROSE trial⁴⁴ and in the study reporting the main results.⁴⁵

PRIMROSE Study Design and Participants

The PRIMROSE intervention was delivered by nurses at CHCs in eight Swedish counties and was directed toward first-time mothers and fathers attending regular check-ups. Balanced (1:1) randomization was undertaken at the CHC unit level within each of the 8 counties, resulting in 31 units allocated to the intervention and 28 to the control.

The duration of the intervention was ∼39 months, and it started when the children were 9 months old, and ended when the children were 4 years old. Families with 1369 children enrolled in the trial and provided written informed consent. Families were excluded if they had limited skills in the Swedish language, were about to change their CHC, or had severe family problems (e.g., ongoing divorce). The control group received care as usual, consisting of regular check-ups at the CHCs, which took place when the children were ∼9–10 months, 1.5 years, and at ages 2, 3, 4, and 5–5.5 years. The service is a well-established part of the nationwide Swedish child health promotion and surveillance system and almost all Swedish parents attend the regular check-ups. The Regional Ethical Review Board in Stockholm, Sweden granted approval for the PRIMROSE trial (2006/525-31/2, 2008/1256-32), and the trial was registered at the ISRCTN registry (ISRCTN16991919).

Intervention

The aim of the intervention was to promote healthy food and PA habits among the parents and their children. The intervention was manual-based and consisted of nine sessions, of which six were individual sessions, one group session, and two delivered by telephone. The six individual sessions were delivered in conjunction with the regular check-ups, the group session 1 month after the first session, and the telephone calls when the child was ∼2.5 and 3.5 years old. The intervention was based on social cognitive theory,⁴⁶ included principles of cognitive behavioral therapy,⁴⁷ and was developed by members of the study team who were experts within the fields of psychology, childhood obesity, nutrition, and child healthcare. The intervention was delivered within the frame of MI,³² with the aim to motivate the parents to obtain and/or maintain healthy habits and subsequently become role models for their children. When the children grew older, the parents were provided with skills on how to directly influence their children's eating and PA habits.

The nurses participated in a 5-day workshop about the PRIMROSE intervention, including an introduction to its theoretical basis, nutrition, PA, and 3.5 days of training in MI. The training was led by experts within each field and has been described in detail elsewhere.^44,48,49

Assessment

Participating nurses measured children's height and weight once a year; when the children were ∼9 months and 2, 3, 4, and 5 years old. Gender and age specific cutoff points for overweight and obesity were based on internationally accepted criteria.⁵⁰ In the current study, the data at age 5 were used, and for the children whose BMI was not measured at exactly age 5, we applied growth curve modeling, using nonparametric regression (kernel smoothing) to estimate their BMI at that age.⁵¹

Data on parental food habits were collected at baseline, using a semi-quantitative food frequency questionnaire, which was validated against a food diary kept for two periods of 4 days.⁴⁴ Specific food items were chosen based on recommendations from the Swedish National Food Administration⁵² and categorized into two variables. Healthy intake comprised fruit, vegetables, and fish, and unhealthy intake comprised French fries, sugared drinks, and discretionary calories (products that are high in energy but have little nutritional value).

Parents' PA was assessed at baseline by the Baecke questionnaire, which covers PA at work, sports during leisure time, and PA during leisure time excluding sports, and has shown adequate construct validity and test–retest reliability.⁵³ Parents also answered a questionnaire about their weight, height, and sociodemographic circumstances and were also instructed to measure their WC using a measuring tape provided by the research team.

Statistical Analyses

Differences between intervention and control groups at follow-up were analyzed using all randomized participants with observed outcome data. Children's weight and height at age 5 were collected from CHC units' records, which did not require any parental involvement, and the attrition rate was only 5%, thus no imputations were made. The trial arms were compared using linear regression models on continuous outcome variables and Poisson regression models on binary outcomes to estimate relative risks (RR). Generalized estimating equations (GEE) with robust variance estimates were used, taking into account the clusterrandomized design. GEE regression models were also used to explore potential moderation by evaluating the interaction of group × moderator. Outcome variables in the current study were children's BMI, overweight, and obesity at 1-year follow-up, when the children had reached 5 years of age. The moderators were baseline parental PA, education, healthy/unhealthy eating, BMI, overweight, obesity, and WC. Bonferroni corrections for multiple comparisons were made post hoc (i.e., 0.05 divided by 27 = 0.0018), taking into account the number of analyses performed. Interaction models were adjusted for baseline parental age, education and country of birth (with the exception of analyses where any of these variables were analyzed as potential moderators), which all correlated to varying extent with child's weight status (outcomes) and lifestyle behaviors (moderators), and thus qualify as potential confounders. Correlations between the confounders and moderators varied from around −0.25 to 0.25.

Results

Previous recruitment and attrition of participants from pre- to post-assessment have been described in detail elsewhere.⁴⁵ Anthropometric data of 1148 children were obtained at post-intervention, whereas at follow-up, anthropometric data of 1091 children (5% attrition rate from post-intervention to follow-up) were obtained. There were no statistically significant differences regarding baseline characteristics of participants remaining in the trial and those lost to follow-up (data not shown). Information on participants' characteristics at baseline is shown in Table 1.

Table 1.

Baseline Characteristics of the Participants

	Intervention % (n) or mean (SD)	Control % (n) or mean (SD)
Mothers	n = 431	n = 599
Age (years)	30.3 (5.1)	29.7 (4.9)
BMI	24.7 (4.6)	24.9 (4.7)
Overweight^a	37.9 (163)	39.4 (235)
Postsecondary education	67.5 (291)	59.9(358)
Born in Sweden	95.4 (416)	90.2 (587)
Parental self-efficacy	127.1 (16.4)	126.3 (16.0)
Fathers	n = 374	n = 431
Age	33.0 (5.73)	32.5 (5.9)
BMI	25.7 (3.51)	25.9 (3.6)
Overweight^a	52.3 (195)	52.6 (225)
Postsecondary education	49.5 (185)	43.4 (187)
Born in Sweden	95.8 (365)	92.7 (467)
Parental self-efficacy	121.4 (17.6)	120.1 (17.4)
Children	n = 436	n = 655
Girls	48.2 (210)	43.8 (287)
BMI^b	17.3 (1.3)	17.4 (1.3)

Including obesity.

BMI predicted at age 1 year.

Table 2 shows BMI and the prevalence of overweight and obesity when the children were 5 years old. There were no significant differences between the control and the intervention group on any of these variables, and the results did not differ between boys and girls (not shown).

Table 2.

Comparisons between the Intervention and Control at 1-Year Follow-Up

	Intervention (n = 436), mean (SE)	Control (n = 655), mean (SE)	Mean difference/RR (95% CI)	p
BMI	15.8 (0.09)	15.9 (0.08)	−0.13 (−0.11–0.37)	0.29
Overweight^a (%)	15.5 (0.02)	16.2 (0.02)	0.96 (0.70–1.30)	0.78
Obesity (%)	2.1 (0.01)	3.8 (0.01)	0.57 (0.24–1.36)	0.20

Including obesity.

CI, confidence interval; SE, standard error.

The results from the analyses of potential moderators are presented in detail in the Supplementary Table S1 (Supplementary Data are available online at www.liebertpub.com/chi). Maternal WC significantly moderated the effect of the intervention in terms of children's BMI (β = −0.02, p = 0.034) and overweight status (RR = 0.98, p = 0.048), and maternal unhealthy eating significantly moderated the effect of the intervention in terms of children's overweight (RR = 0.94, p = 0.013). Paternal PA significantly moderated the effect on children's obesity (RR = 0.56, p = 0.025). All significant moderators influenced the difference between the trial arms in favour of the intervention; that is, the higher the level of the moderator the lower the BMI or the lower the risk of overweight/obesity in the intervention group compared with the control group. However, the differences were of small magnitude and none of the results remained significant after Bonferroni correction for multiple comparisons.

Discussion

In the present study, our primary aim was to investigate weight-related outcomes of the PRIMROSE trial at 1-year follow-up when the participating children had reached 5 years of age. Our results showed no statistically significant effect of the intervention in terms of BMI or prevalence of overweight or obesity. The results are in line with those obtained at post-intervention.⁴⁵

Our secondary aim was to analyze the potential moderating effects of baseline factors in terms of parents' weight-related measures, eating, PA, and educational level on children's weight-related outcomes at follow-up. Although the moderation analysis indicated some intervention effect for children of mothers with higher WC and more unhealthy food intake, and fathers with lower levels of PA, the effects were small (according to the β and RR coefficients) and did not remain statistically significant after correction for multiple comparisons. In addition, the number of 5-year-old children with obesity was small (9 in the intervention group and 25 in the control condition), rendering the analyses of this outcome variable less reliable. The most likely interpretation of the results is that parental baseline factors (PA, education, eating habits, BMI, WC, and prevalence of overweight/obesity) did not moderate the effect of the intervention. Two meta-analyses, of which one included both treatment and prevention trials and the other both selected and universal trials have suggested lack of evidence for moderating effects.^16,20 The baseline variables investigated in one of the meta-analyses were child age, gender, ethnicity, and baseline weight of child and parent, of which none was a significant moderator.¹⁶ In the other meta-analysis, child age, gender, ethnicity, and risk status (selected or universal trials) were analyzed, with stronger effects for interventions targeting children, adolescents, and females only.²⁰ However, there's a lack of obesity prevention trials examining parental characteristics as potential moderators of the effect.^17,18,41

Reviews have emphasized the need for long-term follow-ups of prevention trials within child healthcare settings targeting parents of young children.^17,19,27,28 There is also a need for more interventions aimed at universal/primary prevention,²⁴ although our results did not support effectiveness in influencing weight-related outcomes. The results correspond with previous studies evaluating MI as a method for obesity prevention,^54–56 although one study was directed toward infants,⁵⁶ one toward 4–7-year-old children with overweight,⁵⁵ and another toward 6-year olds in disadvantaged areas.⁵⁴ We were not able to find a study corresponding to the design of the PRIMROSE trial, but systematic reviews of childhood obesity prevention targeting parents of preschool children generally show small or no significant effects on weight status at follow-up.^16,27

Some previous prevention studies have shown delayed effects,^30,31,57 and in the absence of long-term follow-ups of universal/primary prevention trials,^16,24 a longer follow-up period could possibly have detected effects with later onset, especially considering that the PRIMROSE intervention showed positive effects on mothers' and children's diet.⁴⁵ However, the effect on diet was small and should be interpreted with caution,⁴⁵ particularly since prior prevention studies have suggested that improvements on diet might not be related to weight-related outcomes.^20,24 Also, systematic reviews and meta-analyses show a general tendency of short-term results not being sustained at follow-up.^16,20,24,41

According to some investigators, weight-related measures collected at a specific age might not be an optimal indicator for obesity later in life; instead, BMI growth patterns (e.g., low birth weight followed by accelerated growth) might be more reliable indicators.^21,58,59 Nevertheless, in two systematic reviews of childhood predictors of adult obesity, both childhood growth patterns and childhood obesity, were significant predictors.^60,61

The duration of the nine-session intervention was ∼39 months, and the rather long intervals between the last sessions might have made it difficult for parents to maintain their motivation to focus on healthy eating habits and PA. In a meta-analysis of childhood obesity prevention studies, duration of the intervention was negatively associated with the outcome, with no significant effect for interventions longer than 16 weeks.²⁰ Another more recent meta-analysis, specifically focusing on interventions directed toward parents of preschool children, did not find a significant relationship between duration and outcome.¹⁶ In addition, the intensity of the intervention might have been too low, since most interventions which have shown some preventive effects have been fairly intensive.²⁰ There is also some evidence indicating that simple one-component interventions are more effective than interventions including multiple components (e.g., both interactive sessions and educational materials), hence, the current program might have been too complex.^16,20

Another possible explanation for the results is the low levels of attained MI proficiency among the intervention nurses, which has been previously reported.^48,62 However, it has been indicated that the nurses had difficulty identifying target behaviors for already motivated and healthy parents, which suggests that MI might not be suitable for primary prevention, and that the measurements of proficiency, which were based on recordings of intervention sessions, could be misleading.^48,62

A more intensive intervention with more sessions during a shorter time-frame, followed by long-term booster sessions, might have been more efficient in promoting and maintaining behavior change. However, lack of time and resources at the Swedish CHCs would probably have made such an approach hard to implement.

Although there were limitations to the current study, there were also considerable strengths; the large sample, the use of a control group, the theoretical underpinning, the focus on parents of young children, and the implementation at CHCs; services that are visited by almost all Swedish parents of 0–6-year-old children.

The difficulty to develop and implement effective prevention programs is not unique to obesity prevention, but a common problem when it comes to prevention of unhealthy behaviors.²⁰ There is a need for more studies investigating what behavioral change targets and techniques are most effective in influencing lifestyle changes and a need for a common terminology when describing the content of interventions.^63–65 In addition, most studies do not attempt to influence environments outside the family or preschool/school; hence, more interventions also targeting the macroenvironment/societal level are called for.^21,66–68

Conclusions

The results from this follow-up study suggest that a universal primary prevention intervention based on MI, directed toward parents of young children and delivered within child health services, might not be effective in influencing children's weight measures in the longer term. Lack of expected outcome in the current trial calls for increased attention to individual and contextual factors as well as intervention characterics (e.g., dose, duration, and intensity) that might be important determinants of positive long-term results.

Footnotes

Acknowledgments

F.R. is principal investigator of the PRIMROSE trial. The PRIMROSE trial has been supported by grants from the following agencies: the Swedish Research Council for Health, Working Life and Welfare (2006-0226 and 2011-0413), the Swedish Research Council (K2006-27X-20069-01-3 and K2012-69X-22058-01-3), the Research and Development Committee, Stockholm County Council (2006-0324), the Regional Research Council of the Uppsala and Örebro Healthcare Region (RFR-12404), Uppsala County Council, Sörmland County Council, the Public Health Committee of Stockholm County Council (0803-377), the Vårdal Foundation (B2007-006), AFA Insurance (H-06:05/070001), the Foundation of the Swedish Diabetes Society (TMA2006-004), and the Karolinska Healthcare Sciences Postgraduate School (2008). The trial has also received faculty funds from the Karolinska Institutet for PhD student grants (2012 and 2013).

Author Disclosure Statement

No competing financial interests exist.

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