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Completed

NCT Number: NCT03738540

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TALK study group

Behavioral

Telephone Delivered Intervention

TALK control group

Behavioral

Telephone Delivered Intervention

Primary outcomes

  1. 12-month weight loss

    Time frame: 12 months post randomization

    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.

Secondary outcomes

  1. 3-month weight loss

    Time frame: 3 months post randomization

    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.

  2. 6-month weight loss

    Time frame: 6 months post randomization

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

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

Acronym: WeLNES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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