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Habitual and Neurocognitive Processes in Adolescent Obesity Prevention

Primary Purpose

Obesity, Behavioral Intervention, Obesity Prevention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cue and Implementation Intention-Based Intervention
Control arm
Sponsored by
Claremont Graduate University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • failure to meet inclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Cue and Implementation-Intention

    Control Arm

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Sugar-Sweetened Beverage servings/day
    Change in Sugar-Sweetened Beverage consumption after intervention, through survey administration
    Salty Snack servings/day
    Change in Salty Snack consumption after intervention, through survey administration
    Sweet Snacks servings/day
    Change in Sweet Snack consumption after intervention, through survey administration

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2017
    Last Updated
    May 29, 2017
    Sponsor
    Claremont Graduate University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03165903
    Brief Title
    Habitual and Neurocognitive Processes in Adolescent Obesity Prevention
    Official Title
    Habitual and Neurocognitive Processes in Adolescent Obesity Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (Actual)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Claremont Graduate University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    See above.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Behavioral Intervention, Obesity Prevention, Diet, Adolescents

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    187 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cue and Implementation-Intention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Arm
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cue and Implementation Intention-Based Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control arm
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Sugar-Sweetened Beverage servings/day
    Description
    Change in Sugar-Sweetened Beverage consumption after intervention, through survey administration
    Time Frame
    3 months
    Title
    Salty Snack servings/day
    Description
    Change in Salty Snack consumption after intervention, through survey administration
    Time Frame
    3 months
    Title
    Sweet Snacks servings/day
    Description
    Change in Sweet Snack consumption after intervention, through survey administration
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: failure to meet inclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kim D Reynolds, PhD
    Organizational Affiliation
    Claremont Graduate University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.

    Learn more about this trial

    Habitual and Neurocognitive Processes in Adolescent Obesity Prevention

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