Clinical trial NCT03738540: Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study
Official title: Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight, Body
Keywords: Weight loss
Nutrition
Exercise
Diet
Telephone coaching
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on proven success using ACT telephone counseling intervention for smoking cessation.

Detailed description: There is consistent evidence from observational studies that higher amounts of body fat are associated with increased risks of cancer. Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. However, this study required in-person clinic visits with treatment groups, which limits its potential reach and disseminability. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on our proven success using ACT telephone counseling intervention for smoking cessation. There will be a two-arm pilot randomized trial (N = 100), comparing the ACT telephone intervention to a standard behavioral treatment (SBT) telephone control. The pilot RCT will yield engagement, receptivity, and preliminary weight loss results that will provide critical and timely weight loss intervention data.

Eligibility criteria: Inclusion Criteria:

* age 18 or older,
* overweight or obese (BMI ≥ 27),
* wants to lose weight through healthy behavior change, beginning in the next 30 days,
* interested in learning skills to lose weight,
* willing to be randomly assigned to either condition,
* resides in 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,
* not pregnant or planning to become pregnant 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 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, and
* has not participated in our other ACT interventions. To increase follow-up data retention, eligibility criteria also include:
* willing to complete the follow-up survey, and (16) provide email, phone, and mailing address.

Exclusion Criteria:

* Opposite of the inclusion criteria

Primary outcomes:
measure: 12-month weight loss
timeFrame: 12 months post randomization
Secondary outcomes:
measure: 3-month weight loss
timeFrame: 3 months post randomization
measure: 6-month weight loss
timeFrame: 6 months post randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Jonathan Bricker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bricker JB, Mull KE, Sullivan BM, Forman EM. Efficacy of telehealth acceptance and commitment therapy for weight loss: a pilot randomized clinical trial. Transl Behav Med. 2021 Aug 13;11(8):1527-1536. doi: 10.1093/tbm/ibab012.