NCT03165903

Brief Summary

The study tested an intervention that used a cue-removal and implementation intentions based strategy to change habitual dietary behaviors. The intervention was evaluated using a randomized experimental design that consisted of two conditions including (1) a control condition or (2) a cue and implementation intention-based intervention. High schools (N=22) were randomly assigned to one of the two conditions. Families (N=187), with a family defined as an adolescent and one participating parent, were recruited from within the 22 schools. All of the families from each school were assigned to the same condition. Families that were eligible for the study and that were interested in participating scheduled an appointment to complete informed consent. After written parental consent and youth assent was obtained, the participants had their height and weight measured and completed a series of questionnaires programmed on laptops. In addition, the adolescent took part in a 24 Hour Dietary Recall Assessment. The family was also informed that a second 24 Hour Dietary Recall Assessment would be administered to the adolescent over the phone in approximately 3-14 days. Families that were from a school assigned to the control condition received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, two generic newsletters, an email, and a text message. Families from a school assigned to the cue- and implementation intentions condition received an intervention on healthy snacking and the reduction of sugar sweetened beverage consumption that consisted of a 90-minute meeting with a trained Health Coach, two 20-minute phone calls, four tailored newsletters, and a series of emails and text messages. Both of these interventions were delivered over a period of 3-10 weeks depending on the self-directed pace of the participants. All participants were then asked to complete a follow-up assessment appointment three months after their original consenting appointment. Our hypotheses focused on dietary behaviors and stated that adolescents assigned to the cue-removal and implementation intentions intervention would consume significantly fewer daily servings of high fat snacks, high sugar snacks, and sugar sweetened beverages than adolescents in the control condition.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 23, 2017

Last Update Submit

May 29, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sugar-Sweetened Beverage servings/day

    Change in Sugar-Sweetened Beverage consumption after intervention, through survey administration

    3 months

  • Salty Snack servings/day

    Change in Salty Snack consumption after intervention, through survey administration

    3 months

  • Sweet Snacks servings/day

    Change in Sweet Snack consumption after intervention, through survey administration

    3 months

Study Arms (2)

Cue and Implementation-Intention

EXPERIMENTAL

Families from a school assigned to Cue and Implementation Intention-Based Intervention received an intervention targeting increased levels of healthy snacking and reduced levels of sugar sweetened beverage consumption.

Behavioral: Cue and Implementation Intention-Based Intervention

Control Arm

OTHER

Families that were from a school assigned to Control received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, 2 generic newsletters, an email, and a text message.

Behavioral: Control arm

Interventions

Families from a school assigned to Cue and Implementation Intention-Based Intervention received an intervention targeting increased levels of healthy snacking and reduced levels of sugar sweetened beverage consumption. The intervention consisted of a 90-minute meeting with a trained Health Coach, two 20-minute phone calls, 4 tailored newsletters, and a series of emails and text messages. Cues for snacking and sweetened beverage consumption were removed or relocated and implementation-intentions were created to trigger alternative behaviors to snacking and sweetened beverage consumption in the presence of cues. Both interventions were delivered over 3-10 weeks depending on the self-directed pace of the participants. All participants completed a follow-up assessment 3 months after consent.

Cue and Implementation-Intention
Control armBEHAVIORAL

Families that were from a school assigned to Control received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, 2 generic newsletters, an email, and a text message. Both interventions were delivered over 3-10 weeks depending on the self-directed pace of the participants. All participants completed a follow-up assessment 3 months after consent.

Control Arm

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Eligibility criteria for adolescents included being English-speaking,
  • between the ages of 14 and 17,
  • free of major illness,
  • not receiving clinical treatment for obesity,
  • possessing a cell phone with text messaging capability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kim D Reynolds, PhD

    Claremont Graduate University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

The adolescent baseline and follow-up and parent's baseline and follow up data will be available. The baseline/follow up surveys and data dictionaries will be available. The data are currently available from the Principal Investigator, and the study team is working toward placement of the materials with a national data sharing center.