Haines 2013.

Study characteristics
Methods	Study name: Healthy habits, happy homes Study design: RCT Intervention period: 6 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: parent‐child dyads Unit of analysis: individual
Participants	N (control baseline) = 59 N (control follow‐up) = 56 N (intervention baseline) = 62 N (intervention follow‐up) = 55 Setting (and number by study group): home‐based Recruitment: families were identified from patient records at 4 CHCs that served primarily low‐income, and racial/ethnic minority families. Mailed out potential participants a letter introducing them to the study, inviting them to take part and an opt‐out telephone number should the family choose not to participate. Geographic region: Boston, USA Percentage of eligible population enrolled: 24% of those contacted Mean age: intervention: 4.1 ± 1.1; control: 4.0 ± 1.1 Sex: iIntervention: 43.6% female; control: 51.8% female
Interventions	To examine the effectiveness of a home‐based intervention to improve household routines known to be associated with childhood obesity among a sample of low‐income, racial/ethnic minority families. The Healthy habits, happy homes intervention is a home‐based intervention that uses individually tailored counselling by health educators to encourage behaviour change. The intervention was informed by findings from focus groups with 74 racial/ethnic minority parents of young children. Major components of the intervention included: motivational coaching by a health educator during 4 home visits and 4 health coaching telephone calls mailed educational materials and incentives weekly text messages on adoption of household routines 4 bilingual educators were trained to do the MI during the home visits and coaching calls. Each home visit included: a check‐in to review progress and setbacks to behaviour change discussion of behaviour‐change goals and collaborative goal setting a concrete activity or tool the parent could use to support behaviour change. The monthly coaching calls were designed to assess participants’ progression making changes, provide support for challenges that arose, and reinforce study messages. The intervention focused on promotion of 4 household behaviours: eating meals together as a family, obtaining adequate sleep, limiting TV time, and removing the TV from the child’s bedroom. In addition to the coaching, home visits and calls, parents received text messages twice weekly for 16 weeks and then weekly for the last 8 weeks of the programme. Control: families randomised to the control condition received 4 monthly mailed packages that included educational materials on reaching developmental milestones during early childhood and low‐cost incentives (e.g. coloring books). Diet and PA intervention vs control
Outcomes	Outcome measures Primary outcome: frequency of family meals, child sleep duration, child weekday and weekend day TV viewing, presence of a TV in the room Secondary outcomes: BMI Process evaluation: reported (attendance, satisfaction)
Implementation‐related factors	Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: child: gender, race/ethnicity; parent: education, SES (household income), marital status PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: targeted low‐income, and racial/ethnic minority families Economic evaluation: NR
Notes	NCT01565161 Funding: this work was supported by the CDC and the National Center for Chronic Disease Prevention and Health Promotion (Prevention Research Centers grant 1U48DP00194) Role of the Sponsors: the sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication Participants received USD 40 for completing the baseline visit and USD 50 for completing the 6‐month follow‐up visit. Among the 62 families randomised to intervention, 48 (77%) completed all 4 home visits. Fewer families completed the phone calls; 23 (37%) completed all 4 phone calls. Parents' satisfaction was assessed using a survey to rate how satisfied they were with the programme components and how helpful each component was in guiding their approach to their child’s behaviours. Among the 55 intervention families who completed the process survey at follow‐up, 89% reported being “satisfied” or “very satisfied” with the programme as a whole; 98% were “satisfied” or “very satisfied” with the counselling received during home visits; and 98% were “satisfied” or “very satisfied” with the counselling received during coaching calls. Nearly all parents (98%) reported they would recommend the programme to friends and family.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratum was recruitment site blocked by child sex; condition was assigned by blocks of 4 in each strata. Our statistical programmer used a computerized routine to randomly assign the stratified blocks to the intervention and control condition.
Allocation concealment (selection bias)	Low risk	Assignments were implemented through sealed, sequentially numbered individual envelopes that the research assistant opened following the completion of baseline assessments.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	Overall 92% completed follow‐up; 8% individual attrition (from total families enrolled) with both groups being balanced
Selective reporting (reporting bias)	Low risk	Protocol seen; all outcomes specified in methods have been reported in results
Other bias	Low risk	No other threats to validity