Results Summary
What was the research about?
Childhood obesity is common in the United States. Weight problems during childhood can lead to long-term health problems, such as high blood pressure, type 2 diabetes, and high cholesterol. Children who have obesity are also at risk of having low self-esteem and depression.
In this study, the research team looked at possible ways to help children and their parents manage children’s weight. The team assigned children whose weight was higher than the healthy range to one of two groups. In both groups, children and their parents took part in a healthy weight program that included
- Information about how to manage children’s weight
- A neighborhood resource guide
- Monthly text messages
One group also got two extra weekly text messages and had six sessions with trained health coaches. Health coaches worked with children and their families to improve children’s diets, physical activity levels, and motivation.
What were the results?
After one year, children in both groups had lower body mass index (BMI) scores compared with their BMI scores at the start of the study. BMI is a measure of a person’s body fat based on their height and weight. Adding health coaching and extra texts was no more effective than the basic program alone in helping children get to a healthier weight.
Neither program changed the number of children who were in the highest weight category. This group included about 20 percent of the children in the study.
In both groups, parents reported that they had better access to resources to help with their children’s weight than before the study. These resources included farmers’ markets, recreation centers, and community support groups. Only the parents of children who received health coaching reported a better quality of life for their children.
Who was in the study?
The study included 721 children, ages 2 to 12 years, and their parents. The children had BMI scores that were higher than the scores of 85 percent of children of the same age and gender. The children were patients in a large healthcare system in Massachusetts.
What did the research team do?
The study team assigned the children and their parents to one of two groups by chance. One group received materials to help manage children’s weight, a neighborhood resource guide, and monthly text messages about healthy behaviors. The materials urged parents to help their children cut back on sugary drinks, exercise more, limit screen time, and improve sleep habits. The second group received the same materials as the first group plus two extra weekly text messages and six sessions with a trained health coach. The health coaches helped families set goals for managing weight, find local places to exercise, learn to shop for and eat healthy foods, and improve sleep habits.
The research team used the heights and weights from children’s medical records to figure out the children’s BMIs at the start of the study and one year later. In telephone interviews at the beginning and end of the study, parents answered questions about their ability to help their children manage their weight. Parents also reported their feelings about their children’s quality of life related to their weight.
What were the limits of the study?
The study included children who were patients in a large Massachusetts healthcare system. The results may differ for patients who live in other places or receive care in different kinds of medical offices.
These programs didn’t decrease the number of children who were in the highest weight category. Future research could look at how best to help these children.
How can people use the results?
Doctors’ offices and clinics could consider using similar weight-management programs to help children achieve a healthy weight.
Professional Abstract
Objective
To examine the effects of two interventions that leverage clinical and community resources to improve children’s body mass index (BMI), parents’ empowerment, and children’s health-related quality of life
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 721 children, ages 2–12 years, with a BMI≥85th percentile |
| Interventions/ Comparators |
|
| Outcomes |
Change in children’s age- and sex-specific BMI z-score, parent-reported empowerment, and children’s health-related quality of life |
| Timeframe | 1-year follow-up for study outcomes |
This study was a randomized controlled trial to review the effects of two interventions for children with obesity or who are overweight. The primary outcomes of this study were children’s changes in BMI, parent-reported empowerment related to resources available for their children’s weight management, and children’s health-related quality of life.
Researchers randomly assigned 721 patients into one of two arms:
- Enhanced primary care, which included electronic alerts and clinical decision-support tools for pediatric weight management for clinicians as well as educational materials, a neighborhood resource guide, and monthly text messages promoting behavior change for patients.
- Enhanced primary care that included the same components described above, plus contextually tailored health coaching. The health coaching comprised twice-weekly text messages and six sessions by telephone or videoconference or in person with a trained health coach.
The children were ages 2–12 years, with a BMI at or above the 85th percentile, from six primary care practices affiliated with Atrius Health in Massachusetts.
Researchers developed the interventions with input from parents, children, pediatric clinicians, and community health providers.
Researchers obtained height and weight measurements for study participants from electronic medical records at baseline and at one year. They used these measurements to calculate BMI z-scores, which represent age- and sex-specific measures of BMI. BMIs fell into four categories: normal (≥5th to <85th percentile), overweight (≥85th percentile to <95th percentile), obese (95th percentile to <120% of the 95th percentile), and severely obese (≥120% of the 95th percentile). Approximately 21% of study participants had severe obesity at the study outset.
In telephone surveys with researchers at baseline and one year, parents reported their perceived resource empowerment and their children’s health-related quality of life by responding to questionnaires. Investigators documented the children’s race or ethnicity, parents’ educational attainment, household income, and parental satisfaction with the program.
For intent-to-treat analysis, the research team examined the effect of the intervention on the BMI z-score, parental resource empowerment score, and children’s health-related quality of life using linear mixed-effects repeated-measure models.
Results
The addition of health coaches did not improve children’s BMI, increase parental resource empowerment, or improve children’s health-related quality of life more than enhanced primary care alone.
Compared with baseline scores, after one year, BMI z-scores improved significantly both for children who received enhanced primary care (p<0.01) and children who received enhanced primary care plus health coaching (p<0.01). In addition, compared with the beginning of the study, more children who received enhanced primary care (p<0.02) and enhanced primary care plus health coaching (p<0.01) had BMI percentiles in lower categories at the end of the study. However, neither intervention significantly decreased the proportion of children with severe obesity.
After one year, parents of children who received enhanced primary care (p<0.01) and enhanced primary care plus health coaching (p<0.01) reported increased parental empowerment relative to baseline.
Parents of children who received enhanced primary care plus health coaching reported significant improvements in their children’s health‐related quality of life from the beginning of the study to the conclusion of the study (p<0.01). Parents of children who received enhanced primary care alone did not report this improvement.
Limitations
This study took place in a large, multisite pediatric practice in Massachusetts; findings may not be generalizable to smaller practices or in other locations. Post hoc analysis revealed an increase in BMI z-score during the year prior to enrollment in both groups. The research team could not determine whether the interventions alone were successful in reversing the previous upward trend in BMI z-scores or whether the decrease in BMI occurred independently as a natural response to the prior increase.
Conclusions and Relevance
This study found that both enhanced primary care and enhanced primary care plus health coaching improved children’s BMI z-scores and reduced elevated BMIs. Neither of the interventions reduced the percentage of children with severe obesity. Both interventions also improved parental resource empowerment. However, only parents of children who received enhanced primary plus health coaching reported significant improvements in their children’s health-related quality of life.
Future Research Needs
Future research could compare these interventions in different settings, such as smaller pediatric practices, or among populations of different ethnicities and family incomes. Future research could also examine ways to address weight management in children with severe obesity; these children have the highest prevalence of comorbidities and may require more intensive intervention than the enhanced primary care interventions used in this study.
Final Research Report
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Study Protocol
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Reviewers’ comments and the investigator’s changes in response included the following: The awardee revised the conclusions to clarify that there were no differences between children in the two study groups (enhanced primary care and health coaching plus enhanced primary care) regarding body mass index (BMI) or family-centered outcomes. Both groups improved over time in these areas.
- The awardee added a thorough description of the role that patients and stakeholders played in the study design, execution, and interpretation. It also described its website, which provided examples of all patient and stakeholder intervention materials.
- Responding to reviewer comments that the report did not put the changes in outcome measures into a clinical context, the awardee added to the statistical analysis section a description of accepted clinically meaningful changes in BMI, a main outcome measure. The investigator noted that it was unable to add similar values for quality of life, the other major outcome, because any improvement is usually considered clinically meaningful.
- Addressing the patient reviewer’s request to better understand the areas of children’s lives that could be improved by the research, the investigator presented information about family-centered outcomes for childhood obesity that both interventions improved.
- The awardee addressed reviewer questions about blinding. It included a section in the methods describing the procedures for blinding study staff, participants, and clinicians to specific study hypotheses and to intervention assignment.