Diet, Physical Activity, and Weight Trends Study

NCT03609983 | Completed

• 1 other identifier: UTK IRB-18-04488-XP
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to is to examine if self-weighing with feedback, in which the feedback is matched to the timeframe of self-weighing, in the absence of a standard behavioral intervention assists with the self-regulation of energy balance behaviors among young adults. Participants will be randomized to one of three groups: 1) daily weighing; 2) weekly weighing; 3) no weighing for 4 weeks.

Conditions

Self-Regulation

Outcome Measures

Primary Outcomes (2)

• 24-hour Dietary Recall

  Dietary intake data for 24-hour recalls will be collected using the Automated Self-Administered 24-Hour (ASA24), Dietary Assessment Tool, version 2016, developed by the National Cancer Institute, Bethesda, MD. Participants will be registered for ASA24 at the baseline appointment. Throughout the week following the baseline appointment, participants will be randomly emailed on three days to complete three 24-hour recalls (1 weekend day, 2 weekdays) through ASA24. Participants will be randomly emailed again on three days to complete three 24-hour recalls (1 weekend day, 2 weekdays) through ASA24 during the final week of the self-weighing condition.

  Change in diet from Week 1 to Week 5

• Physical Activity

  Activity will be collected with SenseWear Armbands worn by participants for at least 10 hours/day for one week after the baseline appointment and during the final week of the self-weighing condition. The SenseWear Armband utilizes a 2-axis accelerometer to detect motion, a heat flux sensor, galvanic skin response sensor (GSR), skin temperature sensor, and a near-body ambient temperature to calculate energy expenditure. The dependent variables will be total energy expenditure (kJ), moderate- to vigorous-intensity physical activity duration (3.0 METs and higher), and number of steps.

  Change in physical activity from Week 1 to Week 5

Secondary Outcomes (7)

• Weight

  Baseline appointment and follow-up appointment 5 weeks later

• Eating Attitudes

  Baseline appointment and follow-up appointment 5 weeks later

• Binge Eating

  Baseline appointment and follow-up appointment 5 weeks later

• Unhealthy Weight-Control Behaviors

  Baseline appointment and follow-up appointment 5 weeks later

• Self-Esteem

  Baseline appointment and follow-up appointment 5 weeks later

Study Arms (3)

Daily Weighing

EXPERIMENTAL

Participants will weigh themselves daily and receive feedback daily.

Other: Daily weighing with daily feedback on weight

Weekly Weighing

EXPERIMENTAL

Participants will weigh themselves weekly and receive feedback weekly.

Other: Weekly weighing with weekly feedback on weight

No Weighing

NO INTERVENTION

Participants will refrain from weighing themselves.

Interventions

Daily weighing with daily feedback on weight OTHER

Participants will weigh themselves using a Yunmai SE Scale one time each day upon rising from bed beginning in one week, every day for four weeks. After 2 weights have been collected, participants will begin to receive daily feedback on their change in weight and suggestions to maintain energy balance. They will receive an email stating, "Your weight today is \_\_\_\_\_\_\_. Your weight has (increased/decreased) \_\_\_\_\_ pounds since yesterday." If their weight has increased, the email will include one example of how to decrease their energy balance by 150 calories. If participants' weight has decreased, the email will include one example of how to increase energy balance by 150 calories.

Daily Weighing

Weekly weighing with weekly feedback on weight OTHER

Participants will weigh themselves using a Yunmai SE Scale one time each week upon rising from bed beginning the following day for four weeks. After 2 weights have been collected, participants will begin to receive weekly feedback on their change in weight and suggestions to maintain energy balance. They will receive an email stating, "Your weight today is \_\_\_\_\_\_\_. Your weight has (increased/decreased) \_\_\_\_\_ pounds since last week." If their weight has increased, the email will include one example of how to decrease their energy balance by 150 calories. If participants' weight has decreased, the email will include one example of how to increase energy balance by 150 calories.

Weekly Weighing

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between the ages of 18 and 29 years
• body mass index (BMI) 19.0-29.9 kg/m\^2
• weight goal of maintaining current weight/preventing weight gain
• own and iPhone or Android phone to download the Yunmai app for the scale used for self-weighing
• daily access to a computer with internet to complete dietary assessments online through ASA24
• regularly wake up before 12pm (noon) on weekdays (Monday-Friday) and weekend days (Saturday-Sunday)
• present on campus for time period required to complete the study

You may not qualify if:

• self-reported previous or current diagnoses of an eating disorder, or at risk for an eating disorder defined as a score of ≥20 on EAT-26 and/or a score \>27 on BES, and/or report of any extreme unhealthy weight control behaviors
• participating in a program that sets dietary or physical activity goals
• health condition that influences eating or physical activity or requires a therapeutic diet or physical activity restrictions
• allergy to metal making the participant unable to wear BodyMedia SenseWear Armband.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (10)

• Burke LE, Wang J, Sevick MA. Self-monitoring in weight loss: a systematic review of the literature. J Am Diet Assoc. 2011 Jan;111(1):92-102. doi: 10.1016/j.jada.2010.10.008.

  PMID: 21185970 BACKGROUND

• Garner DM, Olmsted MP, Bohr Y, Garfinkel PE. The eating attitudes test: psychometric features and clinical correlates. Psychol Med. 1982 Nov;12(4):871-8. doi: 10.1017/s0033291700049163.

  PMID: 6961471 BACKGROUND

• The National Cancer Institute. Automated Self-Administered 24-Hour Dietary Assessment Tool. The National Cancer Institute. https://epi.grants.cancer.gov/asa24/. Published 2016. Accessed January 18, 2018.

  BACKGROUND

• Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.

  PMID: 7080884 BACKGROUND

• Lopez-Guimera G, Neumark-Sztainer D, Hannan P, Fauquet J, Loth K, Sanchez-Carracedo D. Unhealthy weight-control behaviours, dieting and weight status: a cross-cultural comparison between North American and Spanish adolescents. Eur Eat Disord Rev. 2013 Jul;21(4):276-83. doi: 10.1002/erv.2206. Epub 2012 Oct 11.

  PMID: 23055262 BACKGROUND

• Heatherton TF, Polivy J. Development and validation of a scale for measuring state self-esteem. Journal of Personality and Social Psychology. 1991;60(6):895.

  BACKGROUND

• McNair D, Lorr M, Droppleman L. Profile of mood state manual. San Diego (CA): Educational and Industrial Testing Service. 1971.

  BACKGROUND

• Garner DM. Eating attitudes test (EAT-26): Scoring and interpretation. http://www.eat-26.com/Docs/EAT-26IntpretScoring-Test-3-20-10.pdf. Accessed February 20, 2018.

  BACKGROUND

• Cotter EW, Kelly NR. Binge Eating Scale (BES). In: Wade T, ed. Encyclopedia of Feeding and Eating Disorders. Singapore: Springer Singapore; 2016:1-5.

  BACKGROUND

• Marcus MD, Wing RR, Hopkins J. Obese binge eaters: affect, cognitions, and response to behavioural weight control. J Consult Clin Psychol. 1988 Jun;56(3):433-9. doi: 10.1037//0022-006x.56.3.433. No abstract available.

  PMID: 3397436 BACKGROUND

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Genevieve Prushinski

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A 3x2 mixed factorial design will be used, with a between-subject factor will of self-weighing group (daily weighing; weekly weighing; and no weighing control group) and within-subject factor will of time (prior to self-weighing and feedback and during self-weighing and feedback).

Study Record Dates

• First Submitted: June 17, 2018
• First Posted: August 1, 2018
• Study Start: June 12, 2018
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)