The WEIGH Study: Weighing to Improve and Gain Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dori Steinberg, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01369004
First received: June 2, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

The purpose of this research project is to assess the efficacy of a weight loss intervention for chronic disease prevention that focuses on daily self-weighing as the primary self-monitoring strategy compared to a delayed-intervention control group. While daily self-weighing has been shown to be effective for weight loss in observational research, there is limited experimental evidence testing this association and most is derived from intensive interventions that may overshadow the effects of self-weighing. To mitigate this, the investigators will examine whether daily self-weighing is effective for weight loss under self-directed conditions using a randomized-controlled design.

The investigators will conduct a 6-month randomized trial in 88 overweight and obese adults to compare a daily self-weighing intervention to a delayed-intervention control group. Changes in weight, diet and physical activity, and psychosocial measures will be examined.

Main Study Hypothesis: Participants in the group randomized to receive the daily self-weighing intervention will have greater percent weight loss at 6 months compared to those in the delayed control group.

Secondary Hypothesis: Participants in the group receiving the daily self-weighing intervention will report greater engagement in diet and physical activity behaviors that produce caloric deficits, greater self-efficacy and motivation, and no differences in body satisfaction, disordered eating, or depressive symptoms compared to those in the control group.


Condition Intervention
Overweight and Obesity
Behavioral: Daily Self-weighing + weekly feedback+ weekly lessons

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Weight Tracking Technology to Promote Weight Loss Among Overweight Adults

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Percent Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary outcome is percent weight loss at 6 months. Weight will be collected at baseline, 3, and 6 months at the UNC Weight Research Program Center and measured to the nearest 0.2 lbs using a digital Tanita scale that will be calibrated routinely. Participants will weigh-in wearing light clothes and no shoes


Secondary Outcome Measures:
  • Changes in Caloric Intake [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Caloric intake will be assessed at baseline, 3 and 6 months using the online Automated Self-Administered 24-hour recall tool created by the National Cancer Institute.

  • Changes in Energy Expenditure from Exercise [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Energy expenditure from exercise will be assessed at baseline, 3, and 6 months via the Paffenbarger Exercise Habits Questionnaire.

  • Changes in Self-efficacy for Eating Behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess self-efficacy for eating behaviors related to weight control at baseline, 3 and 6 months using the Weight Efficacy Lifestyle Questionnaire.

  • Changes in self-efficacy for exercise behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess self-efficacy for exercise behaviors at baseline, 3 months, and 6 months using the Sallis Self-efficacy for Exercise Behaviors Questionnaire.

  • Changes in Weight Control Strategies (diet and exercise) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At baseline, 3months, and 6 months, we will assess behavioral strategies (both diet and exercise) associated with successful weight control using the Eating Behavior Inventory and the Weight Management Strategies Questionnaire. These strategies have been shown to be associated with greater weight loss in other weight control trials.

  • Changes in Motivation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess autonomous and controlled motivation at baseline, 3 months, and 6 months using the Treatment Self-Regulation Questionnaire.

  • Changes in Dietary Hunger, Restraint, and Disinhibition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess dietary hunger, restraint, and disinhibition at baseline, 3 months, and 6 months using the Three Factor Eating Questionnaire.

  • Changes in Binge Eating symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Questionnaire on Eating and Weight Patterns-Revised will be administered at baseline, 3 months, and 6 months to assess changes in behaviors related to binge eating and bulimia.

  • Changes in depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Center for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms at baseline, 3 months, and 6 months.

  • Changes in Body Shape Concerns [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Body Shape Questionnaire will be used to assess changes in body shape concerns at baseline, 3 months, and 6 months.

  • Changes in cognitions related to disordered eating [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disordered eating cognitions, patterns, and behaviors will be assessed using a brief version of the Mizes Anorectic Cognitions Questionnaire (BMAC-Q) at baseline, 3 months, and 6 months.


Enrollment: 91
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily self-weighing + feedback/lessons
Participants will be instructed to weigh daily and they will receive a smart scale for daily monitoring of weighing via the website bodytrace.com. They will also receive weekly emailed lessons with content related to behavioral weight control (e.g., How to control portion sizes, How to develop an exercise routine) as well as weekly emailed feedback from a registered dietitian on their daily weighing and weight loss progress.
Behavioral: Daily Self-weighing + weekly feedback+ weekly lessons
Daily self-weighing as a form of self-monitoring of body weight using a smart scale that sends their weights directly to a website (www.bodytrace.com) via the cellular network. They will be able to review weight trends overtime on this website via a graph showing both changes in weight and BMI. They will also receive weekly emailed feedback on their weight loss progress and compliance to the daily self-weighing prescription from a registered dietitian, as well as weekly emailed lessons with content related to behavioral weight control (e.g, how to control portion sizes, how to develop and exercise routine).
Other Name: Daily Self-weighing Intervention
No Intervention: Delayed Intervention Control Group
Participants will receive the same components of the experimental group with the exception of the weekly feedback after the 6-month study period is complete.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between the ages of 18-60 years old
  • Have a BMI between 25-40 kg/m^2 and weigh no more than 310 lbs.
  • Live in the Chapel Hill/Durham/Raleigh, NC area
  • Be able to attend data collection visits at baseline, 3-months, and 6-months at the UNC Weight Research Program Center
  • Have access to the Internet and a computer for daily tracking of weight
  • Be willing to be randomized to either group

Exclusion Criteria:

  • History of psychiatric diseases (bipolar disorder, schizophrenia, hospitalization for depression within the past year), drug or alcohol dependency, or uncontrolled thyroid conditions
  • History of major health conditions, such as heart disease, diabetes, and past incidence of stroke, cancer diagnosis (non-skin) within the past 5 years
  • No physician consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues.
  • Currently pregnant, anticipating on becoming pregnant in the next 9 months, or currently breastfeeding
  • History of eating disorder or currently seeking treatment for an eating disorder.
  • Current participation in a structured weight loss program,or taking weight loss medications
  • Current participation in a weight control study within the past 6 months
  • Current participation in another research study that might affect study hypotheses
  • Have lost 5% of their body weight and kept it off within the past 6 months
  • History of surgery for weight loss
  • Plans to be out of the area for an extensive amount of time without Internet access or move out of the area within the next 9 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369004

Locations
United States, North Carolina
UNC Weight Research Program
Chapel Hill, North Carolina, United States, 27510
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Dori M Steinberg, PhD, MS, RD University of North Carolina, Chapel Hill
Study Director: Deborah Tate, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dori Steinberg, Doctoral Candidate, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01369004     History of Changes
Other Study ID Numbers: 10-2013
Study First Received: June 2, 2011
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
self-weighing
self-monitoring
weight loss
obesity

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014