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.

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Study Start: 2018-01-31
• Primary Completion: 2019-06-29
• Study Completion: 2023-01-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

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.

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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

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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
Weight	baseline & 6 months	absolute change in weight

Secondary Outcome Measures

Name	Time	Method
Compare Cost-effectiveness of interventions	baseline & 6 months	To calculate the cost of the intervention's implementation and compare cost effectiveness of each intervention.
weight loss maintenance	baseline, 6 & 12 months	To experimentally determine the effects of text messaging components and levels on change in 12-month maintenance of weight loss
Change in physical activity	baseline, 6 & 12 months	To experimentally determine the effects of text messaging components and levels on change in physical activity
Change in categorical weight loss (> 5%) at 6-months	baseline, 6 & 12 months	To experimentally determine the effects of text messaging components and levels on change in categorical weight loss (\>5%)
Change in diet	baseline, 6 & 12 months	To experimentally determine the effects of text messaging components and levels on change in diet
Measure engagement in the intervention	baseline, 6 & 12 months	To determine how many responses we receive to our questions and to measure associations of engagement with weight change at 6- and 12- months. We will also model trajectories of change in engagement over time

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States