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Table 2 Clinical effectiveness and related child and family outcomes

From: An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness–implementation trial (Raising Healthy Children study)

Outcome variable(s)

Measure(s) and data collection procedures

Data source and reporter (when applicable)

Child weight and body composition

Portable electronic scale (Tanita SC-331SU) approved by the FDA for BMI and body composition in children (ages 5 to 18) and adults. Child BMI is standardized by sex and age according to the CDC growth reference data for children [121]

Anthropometric

Child dietary habits

NHANES Dietary Screener Questionnaire [122]: 9-point scale (0 = never, 8 = 6 or more times per day) to rate 3 items about fruit, vegetable, and fast-food choices (e.g., “In the past month, how often did you eat fruit?”) and 3 items regarding sugar-sweetened beverage choices (e.g., “In the past month, how often did you drink regular soda that contained sugar?”)

Survey (CG)

Family health routines and health behaviors

(1) Family Health Behaviors Scale [123]: 24 items rated on a 5-point scale (0 = almost never, 4 = nearly always; e.g., “I participate in physical activity with [child name]; [child name] sneaks food”). Caregiver ratings on this scale are sensitive to change and have been shown to predict child weight classification

Survey (CG, CH)

(2) Sleep parenting routines: 6 items on a 5-point scale (0 = almost never, 4 = nearly always; e.g., [child name] goes to bed at about the same time each night). Items developed from existing measures, such as the Brief Infant Sleep Questionnaire [124]

(3) Media parenting routines: 6 items on a 5-point scale (0 = almost never, 4 = nearly always; e.g., “I keep track of [child name]’s screen-time”) and a single question on h per day of media use. Items were drawn from published studies and measures [125]

Parenting and family management skills

Questionnaires encompass 3 domains of parenting and family management skills: (1) positive behavior support, (2) relationship quality, and (3) monitoring and limit setting. Each of these measures has been used in previous FCU trials and was found to have adequate reliability, internal consistency, and sensitivity to change

Survey (CG, CH)

Caregiver: 5-point scale (0 = never, 4 = very often) on the domains of incentives and encouragement (4 items; e.g., “Gave [child name] a hug, kiss, or kind word”) [126]; proactive parenting (7 items; e.g., “Plan for ways to prevent problem behavior”) [127], parent–child conflict (10 items; e.g., “[child name] gets angry at me easily”); family conflict (5 items; e.g., “We got angry at each other”) [126]; quality time (6 items; e.g., “Involve [child name] in household chores”) [127], parent warmth (5 items; e.g., “If upset, [child name] seeks comfort from me”) [128]; family routines (7 items; e.g., “Check to see if [child name] has homework”); limit setting (7 items, e.g., “Speak calmly with [child name] when you were upset with him/her”), negative parent behavior (5 items; e.g., “Criticize [child name]”) [127]; and a single question on h per day of unsupervised time

Child: 4 items on incentives and encouragement (e.g., “Praised you or complimented you for something you did well”), using a 5-point scale (0 = never, 4 = very often); 4-item questionnaire on family conflict (e.g., “I got my way by getting angry”), using a 7-point scale (0 = never, 6 = 8+ times) [126]

Family interaction task (FIT) observational coding system [129]: the recorded family interactions are scored for caregiver(s) behaviors in the domains of relationship quality, positive behavior support, and monitoring and limit setting, as well as demonstrated knowledge of children’s health behaviors (e.g., age-appropriate physical activity duration and dietary guidelines). Child behaviors and emotional adaptation are rated. Each domain is rated for parent’s skill/knowledge on a 5-point scale (1 = low, 5 = high) for each interaction task independently

Observational

Child self-regulation

Caregiver: 13-item survey (e.g., “[child name] is able to resist laughing or smiling when it isn’t appropriate”) adapted from the Children’s Behavior Questionnaire [130], using a 5-point scale (1 = almost always untrue, 5 = almost always true)

Survey (CG, CH)

Child: 16-item questionnaire (e.g., “I pay close attention when someone tells me how to do something”) adapted from the Early Adolescent Temperament Questionnaire [131], using a 6-point scale (1 = always untrue, 5 = always true)

Weight-related stigma

Perception of Teasing Scale [132]: children will use a 5-point scale (1 = never/not upset, 4 = very often/extremely upset) to rate the frequency of 3 events pertaining to weight-related stigma and describe their level of distress associated with these items (e.g., “People made fun of you because you were heavy”; “How upset does this make you?”)

Survey (CH)

Body image

Body Image Scale for Children: a pictorial scale using body pictures representing standardized percentile curves of BMI for boys and girls, separately; good reliability and evidence of validity with children aged 7 to 12 [133]; proxy for satisfaction and a measure of potential adverse effects of participation in the program/study

Survey (CH)

Quality of life

Pediatric Quality of Life Inventory [134]: 23 items in four categories: physical functioning, emotional functioning, social functioning, and school functioning

Survey (CG, CH)

Caregivers: 5-point scale (0 = never, 4 = almost always) to rate items (e.g., “[child name] feels afraid or scared”; “[child name] gets along with other children”)

Children: 3-point scale (0 = not at all, 2 = somewhat, 4 = a lot) to rate items (e.g., “It is hard for me to run”; “It is hard for me to pay attention in school”) adjusted for 2 age groups: 5–7 years old and 8–12 years old

Satisfaction with care

(1) Family Check-Up Caregiver Service Satisfaction Survey: 9 items rated on a 4-point scale (0 = strongly disagree, 4 = strongly agree) adapted from the Client Satisfaction Questionnaire [135] to be specific to parent training programs. This was developed for use with the original FCU conducted in community mental health clinics [89] (α = .95) in that trial

Survey (CG)

(2) Parent Experience of Assessment Survey (PEAS) [136]: 3 of the 5 subscales (parent–coordinator collaboration, systemic awareness, and negative feelings) with 15 total items rated on a 5-point scale (1 = strongly disagree, 5 = strongly agree) (α > .75)

Child adjustment

Strengths and Difficulties Questionnaire [137]: caregivers and children rate 5 items each on a 3-point scale (0 = not true, 1 = somewhat true, 4 = very true) on the conduct problems (e.g., “I/[child name] often lose(s) temper”), hyperactivity (e.g., “I am/[child name] is constantly fidgeting or squirming”), pro-social behavior (e.g., “I am/[child name] is considerate of other people’s feelings”), and emotional problems (e.g., “I am/[child name] is often unhappy, depressed, or sad”) subscales

Survey (CG, CH)

  1. CH child, CG caregiver, CO FCU4Health coordinator, ST stakeholder, EHR electronic health record