Clinical trial NCT03165903: Habitual and Neurocognitive Processes in Adolescent Obesity Prevention
Official title: Habitual and Neurocognitive Processes in Adolescent Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Behavioral Intervention
Obesity Prevention
Diet
Adolescents
Lead sponsor: Claremont Graduate University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 187
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Sugar-Sweetened Beverage servings/day
timeFrame: 3 months
measure: Salty Snack servings/day
timeFrame: 3 months
measure: Sweet Snacks servings/day
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Claremont Graduate University
name: Kim D Reynolds, PhD
role: PRINCIPAL_INVESTIGATOR
References: