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
About this trial
This is an interventional prevention trial for Obesity
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
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
NCT ID
NCT03165903
First Posted
May 23, 2017
Last Updated
May 29, 2017
Sponsor
Claremont Graduate University
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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