Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
Condition: Type2 Diabetes; Sleep
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Enhancing children's sleep duration and/or timing may represent a novel approach for weight
      regulation and prevention of T2DM. The proposed study will assess how experimental changes in
      children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African
      American children ages 8-11 years old who sleep approximately 9.5 hours or less each night
      will be enrolled into a 4-arm randomized controlled pilot to compare three experimental
      manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will
      include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45
      minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-
      and 4-week follow-up, participants be weighed and measured for height, have body fat assessed
      (bod pod), and their blood drawn (following an overnight fast). The pilot will provide
      important data on the potential role of sleep in combating disparities in cardiometabolic
      risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose
      regulation and 2) to determine the effect of changes in sleep on additional measures of
      glucose regulation and adiposity.
    

Detailed description: 
      Eligible families who provide consent/assent will be enrolled into a five week study. All
      families will complete assessments at baseline, two weeks and four weeks. Each assessment
      lasts one week and children will be asked to wear an actigraph on their wrist (to measure
      sleep) and an accelerometer on their hip (to measure physical activity). At the end of the
      week families will be scheduled for a visit at the research center first thing in the morning
      approximately one hour after waking and following an overnight fast. During this visit,
      actigraphs and accelerometers will be downloaded and data will be reviewed with families.
      Children will be weighed and measured for height and have their body composition assessed. To
      measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state.
      They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and
      blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml
      blood will be drawn fasting; OGTT will not be administered (see note below). Research staff
      will also complete one-day dietary recalls with participants at each center-based assessment
      to obtain information on all foods consumed over the previous 24-hour period. In addition, at
      the baseline assessment only, parents will complete questionnaires on basic demographic
      information and child sleep. It is anticipated that the total time for each assessment will
      take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the
      baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by
      90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical
      Sleep Schedule.

      Continuous glucose monitoring In a voluntary subset of randomly selected children
      (approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If
      the child and family agree to participate in CGM, they will come to the Center for an
      additional visit during which a disposable subcutaneous glucose-sensing device connected to a
      battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of
      the skin). This sensor measures glucose every ten seconds and records an average value every
      five minutes.
    

Intervention name(s): Sleep duration 90 min; Sleep duration 45 min; Sleep timing
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Sleep duration: time in bed increased by 90 minutes; Sleep duration: time in bed increased by 45 minutes; Sleep timing: bed time kept consistent
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention