Trial Outcomes & Findings for The Resource Information Program for Parents on Lifestyle and Education (NCT NCT02330588)

Results Overview

Parents' interest was determined by the proportion (indicated as a percentage) of parents that (i) enrolled among those approached to participate, (ii) 'opted in' to receive the tailored email report, and (iii) self-selected resources from the SBIRT; the latter two were recorded by back-end programming of the SBIRT.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

226 participants

Primary outcome timeframe

Baseline

Results posted on

2017-04-17

Participant Flow

A total of 226 participants were recruited from July to October 2015 in a pediatric primary care clinic (Figure 1; http://onlinelibrary.wiley.com/doi/10.1111/ijpo.12200/abstract).

Participant milestones

Participant milestones
Measure	Eat It (Injunctive Feedback) Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with injunctive feedback (i.e., Canadian guidelines).	Eat It (Normative Feedback) Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with normative feedback (i.e., referent data from Canadian children).	Move It (Injunctive Feedback) Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with injunctive feedback (i.e., Canadian guidelines).	Move It (Normative Feedback) Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with normative feedback (i.e., referent data from Canadian children).	eHealth Control Parents randomly assigned to the control arm will include information on children's lifestyle behaviors only (no intervention questions).
Overall Study STARTED	44	43	46	46	47
Overall Study COMPLETED	28	25	31	24	28
Overall Study NOT COMPLETED	16	18	15	22	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Resource Information Program for Parents on Lifestyle and Education

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm (Eat It, Injunctive Feedback) n=44 Participants	Intervention Arm (Eat It, Normative Feedback) n=43 Participants	Intervention Arm (Move It, Injunctive Feedback) n=46 Participants	Intervention Arm (Move It, Normative Feedback) n=46 Participants	eHealth Control Arm (Heads Up) n=47 Participants	Total n=226 Participants Total of all reporting groups
Age, Categorical <=18 years	44 Participants n=5 Participants	43 Participants n=7 Participants	46 Participants n=5 Participants	46 Participants n=4 Participants	47 Participants n=21 Participants	226 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	9.8 years STANDARD_DEVIATION 3.6 • n=5 Participants	9.7 years STANDARD_DEVIATION 3.2 • n=7 Participants	10.3 years STANDARD_DEVIATION 3.9 • n=5 Participants	9.6 years STANDARD_DEVIATION 3.5 • n=4 Participants	10.2 years STANDARD_DEVIATION 2.9 • n=21 Participants	9.9 years STANDARD_DEVIATION 3.4 • n=8 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	21 Participants n=4 Participants	30 Participants n=21 Participants	111 Participants n=8 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	30 Participants n=5 Participants	25 Participants n=4 Participants	17 Participants n=21 Participants	115 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Parents who participated at baseline.

Parents' interest was determined by the proportion (indicated as a percentage) of parents that (i) enrolled among those approached to participate, (ii) 'opted in' to receive the tailored email report, and (iii) self-selected resources from the SBIRT; the latter two were recorded by back-end programming of the SBIRT.

Outcome measures

Outcome measures
Measure	All Groups (Total) n=226 Participants All groups (four brief interventions + eHealth control)	Eat It (Injunctive Feedback) n=44 Participants	Eat It (Normative Feedback) n=43 Participants	Move It (Injunctive Feedback) n=46 Participants	Move It (Normative Feedback) n=46 Participants	eHealth Control n=47 Participants
Feasibility (Parents' Interest in the SBIRT.) Proportion that Enrolled (%)	84.3 percentage of parents	NA percentage of parents Because enrollment happened prior to randomization, per-arm proportions are not available for proportion enrolled.	NA percentage of parents Because enrollment happened prior to randomization, per-arm proportions are not available for proportion enrolled.	NA percentage of parents Because enrollment happened prior to randomization, per-arm proportions are not available for proportion enrolled.	NA percentage of parents Because enrollment happened prior to randomization, per-arm proportions are not available for proportion enrolled.	NA percentage of parents Because enrollment happened prior to randomization, per-arm proportions are not available for proportion enrolled.
Feasibility (Parents' Interest in the SBIRT.) Proportion that Opted into Tailored Report (%)	63.7 percentage of parents	61.4 percentage of parents	62.3 percentage of parents	78.2 percentage of parents	52.2 percentage of parents	63.8 percentage of parents
Feasibility (Parents' Interest in the SBIRT.) Proportion that Self-selected Resources (%)	85.8 percentage of parents	84.1 percentage of parents	86.0 percentage of parents	82.3 percentage of parents	78.3 percentage of parents	95.7 percentage of parents

PRIMARY outcome

Timeframe: One-month follow-up

Population: Participants who completed one-month follow-up.

Parents' uptake was determined by parents' use (actual and self-reported) of obesity prevention resources (i.e., the proportion \[reported in percentage\] that actually or self-reported using resources out of the total number of participants that participated in follow-up), and the proportion (reported in percentage) of parents that reported discussing children's weight with their pediatrician immediately following the SBIRT.

Outcome measures

Outcome measures
Measure	All Groups (Total) n=136 Participants All groups (four brief interventions + eHealth control)	Eat It (Injunctive Feedback) n=28 Participants	Eat It (Normative Feedback) n=25 Participants	Move It (Injunctive Feedback) n=31 Participants	Move It (Normative Feedback) n=24 Participants	eHealth Control n=28 Participants
Feasibility (Parents' Uptake of the SBIRT) Proportion Self-reported Use of Resources (%)	41.2 percentage of participants	35.7 percentage of participants	36.0 percentage of participants	45.2 percentage of participants	37.5 percentage of participants	46.4 percentage of participants
Feasibility (Parents' Uptake of the SBIRT) Proportion Actual use of Resources (%)	16.0 percentage of participants	25.0 percentage of participants	8.0 percentage of participants	16.1 percentage of participants	16.7 percentage of participants	17.9 percentage of participants
Feasibility (Parents' Uptake of the SBIRT) Proportion Reporting Discussing Weight with MD (%)	52.2 percentage of participants	35.7 percentage of participants	40.0 percentage of participants	58.1 percentage of participants	50.0 percentage of participants	46.4 percentage of participants

SECONDARY outcome

Timeframe: Measured at baseline

A brief, eight-item Likert scale questionnaire with established face validity has been adopted from Campbell et al. (2011) and will assess parents' concern for and motivation to support their child's lifestyle behaviors. Concern and motivation to change were measured on a 5-point Likert scale ('strongly disagree' \[0\] to 'strongly agree' \[4\]); for example, "I am ready to change my child's lifestyle behaviors", a 0 would indicate that participants strongly disagree with this statement.