Charge: A Text Messaging-based Weight Loss Intervention

Not Applicable

Completed

Conditions: Obesity
Weight Loss

Interventions: Behavioral: Charge

Registration Number: NCT03254940

Lead Sponsor: Duke University

Brief Summary: This study evaluates different versions of a text messaging-based app for weight loss. This study will place participants to 1 of 32 experimental conditions that reflect different texting components and levels. Participants will be randomized to a condition. The investigators will recruit 448 adults into a 6-month weight loss program, with an additional follow-up 6-months after the intervention ends.

Detailed Description: Standalone text messaging-based weight loss treatments are scalable and can achieve population reach. However, these interventions are also modular; they can be delivered independently to maximize cost-effectiveness or combined with other approaches (e.g. provider counseling) to maximize outcomes. This study is a 12-month experimental trial among 448 adults with obesity. All participants will receive a core 6-month weight loss texting intervention that includes tailored behavior change goals, interactive self-monitoring, automated feedback, and skills training. Participants will be randomly assigned to 1 of 32 different experimental conditions.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 534

Inclusion Criteria

males and females aged 18-65 years
participants have English language proficiency
participants have a BMI between 25-40 kg/m2
Participants will own a smartphone
Participants will be willing to receive multiple text messages daily.

Exclusion Criteria

prior or planned bariatric surgery
psychiatric hospitalization in past 12 months
pregnancy, nursing, or planned pregnancy
history of a cardiovascular event
history of an eating disorder
history of a condition (e.g., end stage renal disease, cancer, schizophrenia) or use of medications (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated, or might promote weight change
current participation in a weight loss trial and/or recent weight loss > 10%
investigator discretion for safety reasons

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1: WT-SM-OR-SS-CS	Charge	Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self
Arm 9: WT-EM-OR-SS-CS	Charge	Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self
Arm 24: DT-SM-MR-SF-CG	Charge	Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group
Arm 2: WT-SM-OR-SS-CG	Charge	Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group
Arm 4: WT-SM-OR-SF-CG	Charge	Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
Arm 7: WT-SM-MR-SF-CS	Charge	Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self
Arm 8: WT-SM-MR-SF-CG	Charge	Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group
Arm 14: WT-EM-MR-SS-CG	Charge	Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group
Arm 15: WT-EM-MR-SF-CS	Charge	Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
Arm 18: DT-SM-OR-SS-CG	Charge	Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group
Arm 19: DT-SM-OR-SF-CS	Charge	Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.
Arm 3: WT-SM-OR-SF-CS	Charge	Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self
Arm 13: WT-EM-MR-SS-CS	Charge	Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
Arm 21: DT-SM-MR-SS-CS	Charge	Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self
Arm 30: DT-EM-MR-SS-CG	Charge	Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group
Arm 32: DT-EM-MR-GF-CG	Charge	Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.
Arm 5: WT-SM-MR-SS-CS	Charge	Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.
Arm 6: WT-SM-MR-SS-CG	Charge	Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
Arm 11: WT-EM-OR-SF-CS	Charge	Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
Arm 12: WT-EM-OR-SF-CG	Charge	Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.
Arm 16: WT-EM-MR-SF-CG	Charge	Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group
Arm 17: DT-SM-OR-SS-CS	Charge	Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.
Arm 10: WT-EM-OR-SS-CG	Charge	Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group
Arm 25: DT-EM-OR-SS-CS	Charge	Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self
Arm 29: DT-EM-MR-SS-CS	Charge	Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
Arm 31: DT-EM-MR-GF-CS	Charge	Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
Arm 20: DT-SM-OR-SF-CG	Charge	Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
Arm 23: DT-SM-MR-SF-CS	Charge	Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.
Arm 27: DT-EM-OR-SF-CS	Charge	Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
Arm 22: DT-SM-MR-SS-CG	Charge	Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
Arm 26: DT-EM-OR-SS-CG	Charge	Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group
Arm 28: DT-EM-OR-SF-CG	Charge	Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group

Primary Outcome Measures

Name	Time	Method
Average Weight Change	baseline, 6 months	Mean change in weight in kg (6 months post-randomization- baseline weight)

Secondary Outcome Measures

Name	Time	Method
Change in Diet	baseline, 6 months	To experimentally determine the effects of text messaging components and levels on change in dietary intake using The Rapid Eating Assessment for Participants - Shortened version (REAP-S). The range of score is 13 to 39, where a higher score indicates more healthy dietary intake.
Average Change in Physical Activity	baseline, 6 months	To experimentally determine the effects of text messaging components and levels on change in weekly minutes of physical activity based on the WHO Global Physical Activity Questionnaire version 2 (GPAC 2). The range of scores is 0 minutes/week to 10,080 minutes/week (maximum number of minutes in a week).