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Completed

NCT Number: NCT03446729

Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching

The objective of this application is to pilot test and evaluate the acceptability and efficacy of a program to facilitate weight loss by enhancing memory for a recently consumed meal.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Once enrolled, all participants will receive behavioral weight loss treatment. Treatment will be 12 weeks in duration and will consist of 7 sessions. The content of sessions will provide the main elements described in behavioral therapy programs for obesity, based on empirical literature. Participants will be provided handouts, and the handout content will be based on our clinic treatment manual and published behavior therapy protocols. The program will be administered in individual 30-60-min sessions with a behavioral coach meeting every other week. This program emphasizes self-monitoring of food intake. It also emphasizes gradual weight loss, increasing physical activity, and improving diet through permanent lifestyle changes. Program topics include: self-monitoring of eating behavior, physical activity, changing the home environment and nutrition education. All treatment sessions will be conducted by licensed clinical health psychologists or psychology doctoral level students with experience in leading weight loss interventions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant must be overweight (BMI between 25-40)
  • Participant must be between the ages of 18-55
  • Participant can read at a minimum of an 5th grade level in English
  • Participant is willing to participate and to commit to 12 weeks of treatment and attendance at assessments

Exclusion criteria

  • Participant is unable to exercise (ex., due to physical or medical reasons)
  • Major psychiatric disorder diagnoses, including an eating disorder
  • Diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet is needed
  • Participant who takes medications that would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status

Treatment and study plan

Guided Self-Help Behavioral Weight Loss

Behavioral

Guided self-help Behavioral Weight Loss including 7 visits over 12 weeks. The treatment content includes self-monitoring, healthy eating, stimulus control, increasing physical activity, reducing sedentary activity, planning ahead for high-risk situations, and relapse prevention. The 7 visits are conducted with a behavioral coach to give participants educational materials and to promote accountability. The behavioral coach's role in the gshBWL program is to measure participant weight, collect self-monitoring booklets, clarify materials, and problem-solve barriers to adherence.

Other names: gshBWL

Primary outcomes

  1. Attendance

    Time frame: Post-Treatment (12 weeks following baseline)

    The number of treatment visits attended

  2. Attrition

    Time frame: Change from baseline at an average of 12 weeks

    The percentage of participant attrition from each treatment arm

  3. Self-Monitoring Adherence

    Time frame: Post-Treatment (12 weeks following baseline)

    The number of days that participants self-monitor

  4. Acceptability

    Time frame: Measured at an average of 12 weeks following baseline

    Average of likert ratings of self-monitoring method, was it "easier," "more helpful," or "more convenient" than any methods participants may have used to self-monitor in the past

  5. Weight Change

    Time frame: Change from baseline at an average of 12 weeks and 24 weeks

    Weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Working Memory

    Time frame: Change from baseline at an average of 12 weeks and 24 weeks

    Digit Span: scaled total forward and backward score

  2. Food specific memory

    Time frame: Change from baseline at an average of 12 weeks and 24 weeks

    A food version of the California Verbal Learning Test. Sum of words recalled across the five recall trials of list A (high calorie food, low calorie food, neutral words) as a measure of global index of verbal learning ability.

Other outcomes

  1. Restraint

    Time frame: Change from baseline at an average of 12 weeks and 24 weeks

    Restraint subscale from the Three Factor Eating Questionnaire

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: TRAC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2018
Registry last updated
Feb 27, 2018

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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