Youth Lifestyle Intervention With Food and Exercise
Condition: Healthy; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Children who are overweight or obese can develop many health complications including
      diabetes, high blood pressure, high cholesterol and they break their bones more often than
      children who are of healthy body weights. Recent short-term studies in children suggest that
      increasing milk intake for 16 weeks begins to improve body composition and also reduces risk
      of developing diabetes. However, no study has been long enough to truly test for the benefits
      of high milk consumption on these conditions including bone. Both dietary and activity
      approaches to reducing obesity in children are suggested by health professionals and when
      combined are called lifestyle interventions. Therefore, McGill University has designed a
      1-year intervention study focused on lifestyle improvements to reduce obesity in children 6
      to 12 years of age. A control group will be monitored for the year, while two other groups
      will receive lifestyle interventions with standard recommended (2 servings a day) and high (4
      servings a day) intakes of milk. The intervention will include 6 planning sessions to
      increase intakes of vegetables, fruits and milks along with more activity and less time
      watching television or using computerized games. Children will have muscle and fat measured
      using an x-ray device that also measures bone at the beginning, middle and end of the study.
      They will also have a small blood sample taken every 3 months to measure blood sugar,
      cholesterol and some nutrients. Changes over the study will demonstrate the benefits of
      lifestyle and milk interventions.
    

Detailed description: 
      Rationale: Childhood obesity is an increasingly major health care problem in Canada. Not only
      are approximately 30% of Canadian children overweight/obese, but they are developing
      significant sequelae including insulin resistance, hyperinsulinemia, hyperlipidemia,
      hypertension, and diabetes mellitus. Additionally obese children have lower bone mass, lower
      25(OH)D concentrations and fracture more frequently. Canadian children on average do not meet
      the recommended intakes for vegetables and fruit and only half of those < 8 years old meet
      the recommended intakes for milk. Obese children are more likely to be inactive and spend
      more screen-time during their free time. There is promising childhood evidence that diets
      with 3 to 4 servings of milk support healthier body composition (lean mass and height) and
      improved insulin sensitivity in the short term and bone mass in the longer term. Family based
      interventions are effective in weight reduction in children. To date, a combined assessment
      of the benefits of improved intakes of milk plus active lifestyles in obese children on body
      composition, bone and blood biochemistry in a family intervention is lacking.

      Objectives and Hypotheses:

        1. To determine if a 1-year lifestyle intervention with planning sessions designed to
           improve diet and activity within the context of the family environment will reduce
           adiposity and elevate lean mass while supporting bone mass in obese children compared to
           a control group and if augmented intake of milk to 4 daily servings will result in
           superior changes. The primary outcome will be change in body mass index (BMI) Z-score
           along with waist circumference for assessment of adiposity; selected for ease of use in
           larger studies or clinics where body composition assessment is not feasible.

           Hypothesis: the lifestyle intervention will yield modest changes to adiposity and lean
           mass accompanied by no reductions in bone mass, but that the augmented milk intervention
           will yield superior reductions in adiposity and elevations in lean and bone mass and
           height growth. It is hypothesized that bone mass will be low and that maintenance of
           bone mass in the standard intervention will thereby be judged as inadequate.

        2. To explain the hypothesized benefits of these interventions on lean, adipose and bone
           masses by measuring indicators of glucose metabolism, satiety and related gut hormones
           along with novel biomarkers of skeletal metabolism including osteocalcin, adiponectin
           and vitamin D.

           Hypothesis: high milk intake will associate with lower glucose, insulin, ghrelin and
           1,25(OH)2D accompanied by higher 25(OH)D, osteocalcin, peptide YY and glucagon-like
           peptide 1.

        3. Test if the intervention with higher milk servings is linked to changes in child eating
           behavior and satiety using the Child Eating Behavior Questionnaire to reflect eating in
           the child's normal environment.

      Hypothesis: children randomized to the high milk intervention group will demonstrate improved
      scores on the satiety responsiveness component of the survey.

      METHODS - Randomized Controlled Trial Ethics: This study was approved by the McGill
      University Institutional Review Board of the Faculty of Medicine in October 2010 and will
      also be conducted in compliance with the Tri-Council Policy Statement 2005 and in compliance
      with local regulation and laws governing research involving human subjects. Otherwise healthy
      obese children (6 to 12 years of age) will be recruited following informed consent. Upon
      completion, the control group will be offered the counseling (5 visits) intervention adjusted
      for age (i.e. counseling + basic anthropometric measurements only).

      Population and Recruitment: Obese children (n=150) from West-Island Montreal and surrounding
      off island areas within 50 km of the Macdonald Campus of McGill University. Our approach to
      recruitment is to use mailings through Canada Post. This service is excellent and the result
      is that for a particular area (predominantly West Island Montreal and off island areas
      towards Ottawa) each household receives a brochure on the study inviting them to attend if
      they have a child who has a body mass index (BMI) in our range. A graph will be provided to
      guide the parents and they will be invited to call us for more information. Obesity will be
      defined on the basis of body mass index > 95th percentile for age according to the World
      Health Organization. In total 150 children 6 to 12 years of age will be recruited over a
      6-month window. Those meeting entrance criteria will be randomized into 3 groups:

        1. a control group with information only (counseling after 12 months for 6-8 year olds and
           after 6 months for 9-12 year olds);

        2. a lifestyle intervention (planning/counseling to improve diet and activity)(6-8 year
           olds only);

        3. the same lifestyle intervention augmented with a total of 4 servings of milk/milk
           products daily (6-12 year olds).

      Study Protocol: Participants will be screened for entrance criteria at a visit 2 weeks prior
      to beginning the 1-year program. Upon confirmation of meeting inclusion criteria, families
      will be telephoned to confirm participation and then 6-8 year olds will be randomized into
      the 3 groups stratified for sex and the 9-12 year olds will be randomized into the 2 groups
      stratified by sex. They (parents & child) will be asked to complete a 3-day diary of food the
      week prior to the baseline visit and at the visit complete questionnaires (activity, eating
      behavior, demographics etc.). These will be used as baseline measures for all groups and for
      the lifestyle intervention groups to guide interventions regarding food choices and activity
      preferences. At the baseline visit, blood sampling, dual energy x-ray absorptiometry (DXA)
      and anthropometric measurements will be completed. All groups will receive simple education
      at the baseline visit regarding Canada's Food Guide and Canada's Activity Guide and given a
      3-day diary to document their food. A registered dietitian will go through the content with
      them to explain how to use the guides and food-diary. Then each group will be seen at 3, 6, 9
      and 12 months of study to obtain new diaries, and perform anthropometric measurements and
      blood biochemistry. Surveys (activity, satiety) will be taken at these visits. Body
      composition and bone mass will be measured at baseline, 6 and 12 months. The intervention
      groups will have lifestyle counseling visits at the end of months 1 through 5 to enable
      individualized family-child counseling (intensive phase) followed by every 3 months
      (establishing phase 9 months plus all receive debriefing at 12 months by a study
      coordinator). Intervention families will receive a monthly telephone call for any outstanding
      issue or to reinforce lifestyle change.

      Details of Family-Child counseling at end of months 1 through 5 plus 9 mo (1.5 h visits):
      Intervention groups will have planning/counseling sessions for a total of 9 hours based on 5
      x 1.5 h visits at the end of months 1 through 5. An additional visit at 9 mo (1.5 h) will be
      used to determine if new diet and activity intervention strategies are necessary over time as
      the child grows/matures and due to season. Counseling visits at end of months 2, 5 and 9
      overlap with regular study visits and will be conducted after study data is collected to
      limit leading and bias (same day if need be to limit travel). All intervention planning
      visits will be with a registered dietitian. Both intervention groups will be instructed in
      detail how to use Canada's Food Guide and Activity Guide (which includes reducing screen
      time) and asked to set goals under the family-based behavioral intervention model of Epstein;
      while considering the environmental and developmental frameworks to arrive at suitable
      planning in the family/near environment plus suitable for the child's developmental age. The
      model of Epstein is grounded in the social learning theory in view of the choices, planning
      and reinforcement, but adapted for children/families resources and environment with
      reinforcement of positive behaviors. Children and families need to change together as a whole
      but also in support of the child being able to make decisions while away from home. This has
      been applied in an intervention to improve asthma control in children at and away from home.

      Canada's food guide servings for Milk and Alternatives (these include for example 250 ml
      fluid milk, 250 ml soy beverage, 175 g yogurt, 175 kefir, 50 g cheese) is 2 per day for
      children 4 to 8 years of age and servings of vegetables and fruits is 5 per day. The
      augmented intervention group will be instructed to consume 4 servings of milk or milk
      products daily (these include for example 250 ml fluid milk, 175 g yogurt, 50 g cheese). The
      4 servings of milk aligns with the recommended servings for 9 to 14 year old children; the
      age at the end of the study or soon thereafter. This intervention approach is both ethical
      and forward-looking. It would be unethical to counsel children and parents to not achieve the
      recommended 2 servings of milk and alternative products for an 8 year old. Upon completion of
      the study the investigators will survey families regarding sustainability of intakes at 4
      servings a day - for children turning 9 years old this is the recommendation.

      The intervention groups will also have counseling on other food groups to result in a healthy
      diet overall. Meal planning at each visit for both interventions will use Canada's Food Guide
      and include age appropriate serving sizes, approaches to combining foods to enhance satiety,
      how to incorporate snacks and fun foods, cooking methods, hidden energy, and how to
      specifically increase vegetables, fruit and milk intakes for the family. The examples of
      servings listed previously are only a few. Within each family food preferences and
      availability will be used to counsel towards achieving 2 or 4 servings of milk and milk
      products a day. Similar family-based dietary interventions have been successfully used in
      overweight and obese children 6 years of age and higher. The intervention groups will also
      actively plan to increase activity according to the Activity Guide which includes increasing
      activity to 90 minutes daily and decrease in non-active time by 90 minutes over 5 months
      (hence the visits at end of months 1 through 5). The new My Food Guide on-line at Health
      Canada offers a convenient tool for planning of both diet and activity that can be used over
      the course of the study in conjunction with the full Health Canada educational tool for
      planning the 5-month increase in activity and reduction in screen time. Planning with parents
      and children together within the context of their environment, developmental stage and food
      and activity preferences is anticipated to improve the program's success. A focus on fun yet
      feasible activities will assist both children and parents in adhering to the program. Expert
      researchers and health care professionals have designed both of these Health Canada tools. In
      fact these tools are used in the Montreal Children's Hospital obesity clinics. The activity
      guide has been successfully used in a 4 week family program to enhance activity.
    

Intervention name(s): 2 servings dairy + exercise; 4 servings dairy + exercise; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects in this group will receive family based counseling to maintain the intake of 2 servings of dairy per day and also receive instruction on how to improve their physical activity.; Subjects in this group will receive family based counseling to increase intake of dairy to 4 servings per day and also receive instruction on how to improve their physical activity.; The group will receive information during the study about diet and exercise but will not receive the intervention until 6 months into the study protocol.
Other intervention name(s): 2 servings of dairy and exercise; 4 servings of dairy and exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: randomized controlled trial; children; obesity; nutrition; exercise