NCT04105309

Brief Summary

One in three college students have overweight or obesity and are in need of brief and simple weight loss interventions that complement their unstructured lifestyles. Implementation intentions, a strategy that connects a goal-aligned behavior to a cue, facilitate goal-attainment for a wide variety of health-behaviors, but have not been tested as a stand-alone treatment for weight loss in students. College students with overweight or obesity (N = 95) were randomized to one of three conditions: an implementation intention group (IMP), an enhanced implementation intention group (IMP+) that included text message reminders and fluency training (i.e., training for speed and accuracy), and a control goal intention group (GOL) for four weeks. Participants completed anthropometric and self-report assessments pre- and post-treatment as well as experience-sampling assessments during the study to assess how implementation intentions contribute more directly to behavior change

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 25, 2019

Last Update Submit

September 25, 2019

Conditions

Keywords

ObesityCollege StudentsImplementation Intentions

Outcome Measures

Primary Outcomes (2)

  • Body Weight

    kilograms

    Measured pre- and post-intervention (4 weeks apart)

  • Relative Body Weight

    Body Mass Index, calculated using both height and weight

    Measured pre- and post-intervention (4 weeks apart)

Secondary Outcomes (2)

  • Kilocalorie Consumption

    Measured pre- and post-intervention (4 weeks apart)

  • Diet Quality

    Measured pre- and post-intervention (4 weeks apart)

Study Arms (3)

Implementation Intention (IMP)

EXPERIMENTAL

Following review of a psychoeducational packet regarding making changes for weight loss, all participants were assigned five dietary goals (e.g. avoiding high-fat foods, eating five servings of fruits and vegetables a day) and a goal to weight daily. Participants in the IMP condition formed an implementation intention for each of the goals at the baseline session. Two examples of implementation intentions were provided for each goal as a model. Participants thought about how they would best be able to achieve the outlined goals in their life on a daily basis (goal-aligned behavior), as well as when, where, and how they would initiate these new behaviors (retrieval cue). Participants then created and wrote down a unique implementation intention for each of the goals using the sentence structure "If/When I \_\_\_\_\_\_\_, then I will \_\_\_\_\_\_." No repetitions or combinations of implementation intentions were allowed for standardization across participants.

Behavioral: Implementation Intentions

Enhanced Implementation Intention (IMP+)

EXPERIMENTAL

Participants completed all tasks of the IMP group and additionally, individuals in the IMP+ condition received fluency training and text message reminders. Fluency training occurred weekly using an online survey tool. On fluency training days, participants received a survey link via email, which consisted of six multiple-choice questions for participant's unique implementation intentions. Participants had to correctly identify their matching goal-aligned behavior among three distractor behaviors as quickly as possible and were given corrective feedback if they chose incorrectly. Text messages containing all six implementation intentions as well as goal reminders that were obtained by asking participants to write down their reasons for wanting to lose weight were sent on four days each week of the intervention (16 days total). At baseline, participants chose how text messages were bundled and when they were sent. Text schedules stayed constant across the study.

Behavioral: Implementation IntentionsBehavioral: Fluency TrainingBehavioral: Text Messages

Goal Intentions (GOL)

ACTIVE COMPARATOR

Participants in the GOL condition were assigned the five dietary goals and the daily weighing goal. No additional intervention was given.

Behavioral: Goal Intentions

Interventions

Implementation intentions aid in pre-planning and habitualization of behaviors, as they serve to identify the when, where, and how of behaviors leading to goal attainment. Often taking the form of "If/when situation x arises, then I will do y!", implementation intentions can be conceptualized in two parts, namely, an environmental or internal retrieval cue and a goal-directed behavioral response. Implementation intentions are effective because they 1) create a strong association between a retrieval cue and a goal-aligned behavior, increasing the likelihood that the goal-aligned behavior will be retrieved and utilized when the cue is encountered, and 2) increase attention for and cognitive accessibility of the retrieval cue, increasing opportunities for goal-aligned action .

Enhanced Implementation Intention (IMP+)Implementation Intention (IMP)

Fluency training is a learning strategy that requires an individual to perform a skill or demonstrate knowledge repeatedly for both accuracy and response rate; the goal is to enhance automaticity of the response and promote endurance and retention of skills and knowledge over time and in the face of distractors. Participants completed 1 minute fluency training protocol 4 times throughout the study.

Enhanced Implementation Intention (IMP+)
Text MessagesBEHAVIORAL

SMS reminders sent to phone of implementation intentions 16 times throughout the study.

Enhanced Implementation Intention (IMP+)
Goal IntentionsBEHAVIORAL

Intentions to complete a goal that do not specify a plan about how to do so (compared to implementation intentions, that do)

Goal Intentions (GOL)

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI greater than or equal to 25
  • Interest in losing weight
  • Own a mobile Smart phone and willing to receive study text messages and download a mobile application

You may not qualify if:

  • Currently participating in a formal weight loss program
  • Meet diagnostic criteria for an eating disorder as measured by the Eating Disorder Diagnostic Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Benyamini Y, Geron R, Steinberg DM, Medini N, Valinsky L, Endevelt R. A structured intentions and action-planning intervention improves weight loss outcomes in a group weight loss program. Am J Health Promot. 2013 Nov-Dec;28(2):119-27. doi: 10.4278/ajhp.120727-QUAN-365. Epub 2013 Apr 26.

    PMID: 23621700BACKGROUND
  • Webb TL, Sheeran P. Mechanisms of implementation intention effects: the role of goal intentions, self-efficacy, and accessibility of plan components. Br J Soc Psychol. 2008 Sep;47(Pt 3):373-95. doi: 10.1348/014466607X267010. Epub 2007 Dec 18.

    PMID: 18096108BACKGROUND
  • Hagger MS, Luszczynska A. Implementation intention and action planning interventions in health contexts: state of the research and proposals for the way forward. Appl Psychol Health Well Being. 2014 Mar;6(1):1-47. doi: 10.1111/aphw.12017. Epub 2013 Oct 8.

    PMID: 24591064BACKGROUND
  • Luszczynska A, Sobczyk A, Abraham C. Planning to lose weight: randomized controlled trial of an implementation intention prompt to enhance weight reduction among overweight and obese women. Health Psychol. 2007 Jul;26(4):507-12. doi: 10.1037/0278-6133.26.4.507.

    PMID: 17605571BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three-group parallel randomized-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

June 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations