Charge: A Text Messaging-based Weight Loss Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention

Conditions
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Weight Loss, Obesity

Intervention / Treatment
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* Behavioral: Charge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: WT-SM-OR-SS-CS<br>Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 2: WT-SM-OR-SS-CG<br>Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 3: WT-SM-OR-SF-CS<br>Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 4: WT-SM-OR-SF-CG<br>Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 5: WT-SM-MR-SS-CS<br>Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 6: WT-SM-MR-SS-CG<br>Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 7: WT-SM-MR-SF-CS<br>Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 8: WT-SM-MR-SF-CG<br>Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 9: WT-EM-OR-SS-CS<br>Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 10: WT-EM-OR-SS-CG<br>Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 11: WT-EM-OR-SF-CS<br>Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 12: WT-EM-OR-SF-CG<br>Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 13: WT-EM-MR-SS-CS<br>Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 14: WT-EM-MR-SS-CG<br>Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 15: WT-EM-MR-SF-CS<br>Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 16: WT-EM-MR-SF-CG<br>Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 17: DT-SM-OR-SS-CS<br>Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 18: DT-SM-OR-SS-CG<br>Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 19: DT-SM-OR-SF-CS<br>Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 20: DT-SM-OR-SF-CG<br>Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 21: DT-SM-MR-SS-CS<br>Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 22: DT-SM-MR-SS-CG<br>Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 23: DT-SM-MR-SF-CS<br>Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 24: DT-SM-MR-SF-CG<br>Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 25: DT-EM-OR-SS-CS<br>Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 26: DT-EM-OR-SS-CG<br>Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 27: DT-EM-OR-SF-CS<br>Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 28: DT-EM-OR-SF-CG<br>Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 29: DT-EM-MR-SS-CS<br>Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 30: DT-EM-MR-SS-CG<br>Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 31: DT-EM-MR-GF-CS<br>Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|
| Experimental: Arm 32: DT-EM-MR-GF-CG<br>Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group. | Behavioral: Charge<br>* Text messaging-based study to determine effect of different components on weight loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | absolute change in weight | baseline & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet | To experimentally determine the effects of text messaging components and levels on change in diet | baseline, 6 & 12 months | 
| Change in physical activity | To experimentally determine the effects of text messaging components and levels on change in physical activity | baseline, 6 & 12 months | 
| Change in categorical weight loss (> 5%) at 6-months | To experimentally determine the effects of text messaging components and levels on change in categorical weight loss (>5%) | baseline, 6 & 12 months | 
| weight loss maintenance | To experimentally determine the effects of text messaging components and levels on change in 12-month maintenance of weight loss | baseline, 6 & 12 months | 
| Measure engagement in the intervention | 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 | baseline, 6 & 12 months | 
| Compare Cost-effectiveness of interventions | To calculate the cost of the intervention's implementation and compare cost effectiveness of each intervention. | baseline & 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, digital health, personalized, text message