Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study

Weight Loss Clinical Trial

— WeLNES  

Official title:

Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738540
• Other study ID #: 8693
• Secondary ID: NCI-2019-02521RG
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss
• Weight, Body

Intervention

Behavioral:
• TALK study group
Telephone Delivered Intervention
• TALK control group
Telephone Delivered Intervention

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month weight loss	Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.	12 months post randomization
Secondary	3-month weight loss	Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.	3 months post randomization
Secondary	6-month weight loss	Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.	6 months post randomization

External Links

•   Study recruitment website