HONOLULU — A large, expensive, randomized trial of intensive primary care counseling failed to have any measurable effect on reducing weight gain in children who were already overweight.
The disappointing results of the 12-month Australian LEAP2 (Live, Eat, and Play) study may have wide-ranging policy implications for governments seeking to avert long-term health costs associated with childhood obesity in developed countries, said Dr. Melissa Wake, director of research and public health at the Centre for Community Child Health in Melbourne.
Despite proving that primary care providers could be trained to deliver brief, comprehensive, family-based, solution-focused therapy, with encouragingly high participation rates, “this intervention, at least, did not have any impact on any primary or secondary outcomes,” Dr. Wake reported in an oral presentation at the annual meeting of the Pediatric Academic Societies. “It was both costly and ineffective.”
Among 3,958 children aged 5–12 years who were screened by primary care providers in Melbourne, 947 (24%) were found to be overweight or mildly obese, and were therefore eligible for a 4-session, 12-week intervention during which the provider individually counseled the family in nutrition, physical activity, and sedentary behavior.
A lengthy initial session was aimed at assessing goals and willingness to change, followed by structured consultations. Extensive materials and accelerometers also were provided to each family.
To learn the techniques, 66 general physicians from 45 practices representing a broad socioeconomic range of families attended two 2.5-hour educational sessions that involved interactive DVD sessions and participated with a trained actor in two simulated family consultations.
Ultimately 258 families were enrolled, 139 assigned to the interventional arm and 119 to the control group, which was provided materials and four physician consultations over 3 months.
Impressive advances were seen in physicians' comfort levels and competency in managing childhood obesity, said Dr. Wake.
At least one consultation session was attended by 96% of families. The mean number of sessions attended was 3, with a range of 1–4. Twelve-month follow-up BMI was available for 94% of children enrolled.
Despite this extraordinary level of participation, the results were dismal, with no statistical change seen at 12 months in the children's or parents' BMI, physical activity, nutrition, or body satisfaction/dissatisfaction.
One child in the intervention group actually gained 10 kg, more than 22 pounds, over the year of the study. The only improvement at 12 months was an increase in psychosocial measures among children participating in the intervention group on the Pediatric Quality of Life: 77.7 on a 100-point scale, compared with 74.4 for children assigned to the control group.
The cost per child was over $1,000, although Dr. Wake noted that the individual cost could be reduced to perhaps $412 if trained physicians were each seeing many children.
Nonetheless, if the program were to be extended to the 250,000 overweight and obese children in Australia the cost would be over $100 million.
Dr. Wake quoted Sir Winston Churchill, who said, “No matter how beautiful the strategy, one occasionally has to look at the results.” In this study, the results didn't justify the costs, with potentially important lessons to be learned for policy bodies in Australia, the United States, and the United Kingdom, all of whom are considering brief primary care interventions in an effort to reduce childhood obesity, she said.