Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversity of Missouri-Columbia

About this trial

The objectives of this open trial feasibility study are to examine the impacts of intensive health behavior and lifestyle treatment (IHBLT) on youth and caregiver executive functioning (EF), weight status, health behaviors (dietary intake, disordered eating, physical activity), and psychological functioning. Investigators propose to enroll 10 youth 13 to 17 years of age who have overweight or obesity (OV/OB) and a primary caregiver. Families will receive six months of evidence-based family focused group IHBLT based on social, cognitive, and family systems theories. Families will complete assessments of EF skills (objective and self-report), weight status, dietary intake, physical activity, and psychological functioning at pre- and post-treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Youth 13-17 years old

Youth with OV/OB (BMI≥85th percentile for age/gender norms)

Participating caregiver must be the participating youth's legal guardian

Participating youth and caregiver speak and read English

Disqualifiers

Youth pervasive developmental disorder (e.g., intellectual disability)

Youth or caregiver in commercial weight loss program or taking prescribed medications for the prior three months that impact appetite or weight

Youth or caregiver with documented history of eating disorder or untreated severe depression

Both youth and caregiver scores are two standard deviations or above the mean on the CPT-3 Commissions and Stroop Interference, representing significantly higher than average EF skills.

Trial design

Design model

Single group

Treatments tested in this trial

  • intensive health behavior and lifestyle treatment

    Behavioral

    the IHLBT will consist of 18 group meetings over 6 months that teens and parents attend. Topics covered during the meetings will include discussions regarding nutrition and physical activity recommendations, family communication, and use of strategies like monitoring, planning, goal setting, and problem solving.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: IHLBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Youth EF - CPT-3 Commissions

Youth T-score on the Continuous Performance Test Third Edition (CPT-3) Commissions subscale; T-scores (M = 50, SD = 10) used with higher scores representing worse executive functioning (EF)

Time frame
Post-Treatment (Month 6)
2

Youth EF - Stroop

Youth T-score on the Stroop Color Word Interference scale; T-scores (Mean = 50, SD = 10) used, with higher scores indicating better executive functioning (EF)

Time frame
Post-Treatment (Month 6)
3

Youth EF - Trails B

Youth Trails B z-score; z-score (Mean = 0, SD = 1), with lower scores indicating worse executive functioning (EF)

Time frame
Post-Treatment (Month 6)
4

Youth EF - BRIEF-2 Self Report GEC

Youth self-report on the Behavior Rating Inventory of Executive Function Second Edition (BRIEF-2) Global Executive Composite (GEC) subscale T-score; T-score (Mean = 50, SD = 10), with higher scores representing worse executive functioning (EF)

Time frame
Post-Treatment (Month 6)

Secondary outcomes

1

Youth Weight Status

Youth body mass index (BMI) BMI z-score calculated based on height and weight measurements; z-scores have Mean = 0 and SD = 1; higher scores indicate higher weight status

Time frame
Post-Treatment (Month 6)
2

Youth Dietary Intake

Youth Total kcals from 24 hour dietary recall

Time frame
Post-Treatment (Month 6)
3

Youth Physical Activity

Youth time spent in moderate/vigorous physical activity on BLOCK screener

Time frame
Post-Treatment (Month 6)

Other outcomes

Sponsors and contacts

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