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Self-Weighing: an Ecological Momentary Assessment (SWEMA)

Primary Purpose

Daily Self-weighing, Daily Temperature-taking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
daily self-weighing
daily temperature-taking
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Daily Self-weighing focused on measuring self-weighing, weight gain, Ecological Momentary Assessment, mood, emerging adulthood, obesity, eating disorders

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • Between the ages of 18 and 26
  • UD student
  • Owns a smart phone
  • If participant does not currently have an eating disorder or has never had one in the past

Exclusion Criteria:

  • If participant currently has an eating disorder or has had one in the past
  • If participant answers "yes" to 3 or more items in SCOFF

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily Self-Weighing Group

Daily Temperature-Taking Group

Arm Description

Participants will be provided with a scale and instructions necessary to engage in daily self-weighing, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.

Participants will be provided with a thermometer and instructions necessary to engage in daily temperature-taking, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.

Outcomes

Primary Outcome Measures

psychological response to daily self-weighing
Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day. The daily self-weighing group will report significantly more weight control behaviors at the end of the day as compared to the daily temperature-taking group.

Secondary Outcome Measures

Identify moderators of response to daily self-weighing in a college-aged female population
Participants with lower baseline dietary restraint scores will experience significantly greater success in preventing weight gain over 3 months in response to daily self-weighing as compared to daily temperature-taking, in comparison to those with higher baseline dietary restraint scores Participants with higher baseline body satisfaction, lower body consciousness, and higher-self esteem will have significantly more favorable reactions to daily self-weighing, both in terms of momentary mood and prevention of weight gain over 3 months Baseline weight status will moderate the effectiveness of daily self-weighing as a weight gain prevention tool, such that it will work significantly better for overweight patients.

Full Information

First Posted
September 1, 2017
Last Updated
October 3, 2018
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT03273491
Brief Title
Self-Weighing: an Ecological Momentary Assessment
Acronym
SWEMA
Official Title
Self-weighing's Psychological Effects: a Randomized Controlled Trial Using Ecological Momentary Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to experimentally test the momentary and more distal psychological effects of daily self weighing as compared to an active control group.
Detailed Description
Two significant public health problems, obesity and eating disorders, are prevalent during emerging adulthood, a unique stage of life between ages 18 and 25. Over half of emerging adults experience weight gain and/or disordered eating (e.g. overly restrictive dieting, binge eating); both of which contribute to obesity. Because many emerging adults attend college, the college community represents a viable population for implementing interventions to prevent weight gain, while not triggering disordered eating. A promising strategy for preventing weight gain during college is daily self-weighing, an example of behavioral self-monitoring, an evidence-based strategy for weight control. Self-monitoring is fundamental to behavior change: feedback allows the user to evaluate progress in relation to a goal and modify behavior. Despite self-monitoring being recommended, some evidence suggests that self-monitoring strategies, self-weighing in particular, may have unintended psychological consequences; the concern being that negative mood states could precipitate disordered eating. Alternatively, other evidence suggests positive psychological outcomes related to daily self-weighing in young adults. Technological advances have allowed for users to track personal health information in real time. Given that 60% of U.S. adults track weight, diet, or exercise, and 92% of adults aged 18-34 own a smartphone, electronic self-monitoring is feasible in this population. What is less known is individuals' psychological and behavioral response to self-monitoring. This original, important study will contribute to the fields of obesity and eating disorders and experimentally test the psychological effects of this daily weight-control intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Daily Self-weighing, Daily Temperature-taking
Keywords
self-weighing, weight gain, Ecological Momentary Assessment, mood, emerging adulthood, obesity, eating disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily Self-Weighing Group
Arm Type
Experimental
Arm Description
Participants will be provided with a scale and instructions necessary to engage in daily self-weighing, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.
Arm Title
Daily Temperature-Taking Group
Arm Type
Active Comparator
Arm Description
Participants will be provided with a thermometer and instructions necessary to engage in daily temperature-taking, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.
Intervention Type
Behavioral
Intervention Name(s)
daily self-weighing
Intervention Description
Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.
Intervention Type
Behavioral
Intervention Name(s)
daily temperature-taking
Intervention Description
Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.
Primary Outcome Measure Information:
Title
psychological response to daily self-weighing
Description
Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day. The daily self-weighing group will report significantly more weight control behaviors at the end of the day as compared to the daily temperature-taking group.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Identify moderators of response to daily self-weighing in a college-aged female population
Description
Participants with lower baseline dietary restraint scores will experience significantly greater success in preventing weight gain over 3 months in response to daily self-weighing as compared to daily temperature-taking, in comparison to those with higher baseline dietary restraint scores Participants with higher baseline body satisfaction, lower body consciousness, and higher-self esteem will have significantly more favorable reactions to daily self-weighing, both in terms of momentary mood and prevention of weight gain over 3 months Baseline weight status will moderate the effectiveness of daily self-weighing as a weight gain prevention tool, such that it will work significantly better for overweight patients.
Time Frame
3 Months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Between the ages of 18 and 26 UD student Owns a smart phone If participant does not currently have an eating disorder or has never had one in the past Exclusion Criteria: If participant currently has an eating disorder or has had one in the past If participant answers "yes" to 3 or more items in SCOFF
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19711
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Self-Weighing: an Ecological Momentary Assessment

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