Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.

ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.

Participants are followed up at 6, 12, and 24 months after randomization.

• Survey Administration (Other): Ancillary studies
• Telephone-Based Intervention (Behavioral): Receive ACT telephone coaching
• Telephone-Based Intervention (Behavioral): Receive SBT telephone coaching

Primary outcomes

• 10% or more weight loss [At 12 months after randomization]: Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression.

Secondary outcomes

• Percent weight change [At 6, 12, and 24-months post randomization]: Will be measured remotely by cellular-enabled scales.
• Dietary intake [At 6, 12, and 24-months post randomization]: Will be measured with the Fitbit smartphone app food logging feature.
• Physical activity [At 6, 12, and 24-months post randomization]: Will be measured with the Fitbit Inspire mailed to participants.
• Trajectories of weight change [At 6, 12, and 24-months post randomization]: Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Overweight or obese (body mass index \[BMI\] >= 27) but not heavier than BMI of 45.5 (measured by weight \& height)
* Wants to lose weight in the next 30 days
* Interested in learning skills to lose weight
* Willing to be randomly assigned to either condition
* Resides in United States (US)
* Has daily access to their own phone and email
* Does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder, and meeting criteria for severe depression (CESD >= 25), or a diagnosis of serious heart disease, diabetes, uncontrolled hypertension, or cancer without written confirmation of approval from their physician office
* Not pregnant, planning to become pregnant or breastfeeding in the next 12 months
* In the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite
* Have not lost more than 5% of their weight in the past 6 months
* Willing and able to read in English
* Not participating in or planning to participate in other weight loss programs
* Has not participated in our other ACT intervention studies
* Does not meet criteria for combined heavy plus binge drinking
* Has access to a Bluetooth-enabled device and Wi-Fi and/or data plan
* Is not planning to have or has not recently had (past 12 months) bariatric surgery
* For outcome data retention, eligibility criteria included: Willing to complete follow-up surveys, and provide email, phone, and mailing address

Exclusion Criteria:

* The reverse of the inclusion criteria

• Informed Consent Form (PDF, 2021-10-26)

• Jonathan B Bricker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: R01DK124114