The WEIGH Study: Weighing to Improve and Gain Health

NCT01369004 | Completed

• 1 other identifier: 10-2013
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

self-weighing; self-monitoring; weight loss; obesity

Outcome Measures

Primary Outcomes (1)

• Percent Weight Loss

  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

  6 months

Secondary Outcomes (11)

• Changes in Caloric Intake

  6 months

• Changes in Energy Expenditure from Exercise

  6 months

• Changes in Self-efficacy for Eating Behaviors

  6 months

• Changes in self-efficacy for exercise behaviors

  6 months

• Changes in Weight Control Strategies (diet and exercise)

  6 months

Study Arms (2)

Daily self-weighing + feedback/lessons

EXPERIMENTAL

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

Delayed Intervention Control Group

NO INTERVENTION

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.

Interventions

Daily Self-weighing + weekly feedback+ weekly lessons BEHAVIORAL

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).

Also known as: Daily Self-weighing Intervention

Daily self-weighing + feedback/lessons

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Weight Research Program

Chapel Hill, North Carolina, 27510, United States

Location

Related Publications (1)

• Steinberg DM, Tate DF, Bennett GG, Ennett S, Samuel-Hodge C, Ward DS. Daily self-weighing and adverse psychological outcomes: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):24-9. doi: 10.1016/j.amepre.2013.08.006.

  PMID: 24355668 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Dori M Steinberg, PhD, MS, RD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Deborah Tate, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 8, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 25, 2017

Record last verified: 2012-09

Locations

US (1)