PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes

NCT02516839 | Completed DMC

• 2 other identifiers: 1511101R01DK103554-01A1
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; Overeating; Body Mass Index; Weight; Treatment; Cravings; Intervention; Behavioral Treatment

Outcome Measures

Primary Outcomes (2)

• body mass index as measured by height and weight

  Time Frame: Change from baseline at an average of 12 months and 24 months

• binge eating as measured by the Eating Disorder Examination

  Change from baseline at an average of 12 months and 24 months

Study Arms (4)

Regulation of Cues (ROC)

EXPERIMENTAL

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning.

Behavioral: Regulation of Cues (ROC)

Behavioral Weight Loss (BWL)

EXPERIMENTAL

The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Behavioral: Behavioral Weight Loss (BWL)

BWL+ ROC

EXPERIMENTAL

BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments.

Behavioral: BWL + ROC

Nutrition Education, Stress Management Social Support

ACTIVE COMPARATOR

Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.

Behavioral: Nutrition Education, Stress Management and Social Support

Interventions

Regulation of Cues (ROC) BEHAVIORAL

Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger,satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.

Also known as: ROC

Regulation of Cues (ROC)

Behavioral Weight Loss (BWL) BEHAVIORAL

All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories (with a calorie counter provided or on their phone), and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.

Also known as: BWL

Behavioral Weight Loss (BWL)

BWL + ROC BEHAVIORAL

BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure sessions in the clinic.

BWL+ ROC

Nutrition Education, Stress Management and Social Support BEHAVIORAL

Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.

Nutrition Education, Stress Management Social Support

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. All participants will be between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and 45. 2. Participants will provide written informed consent for study participation. 3. Participants will possess English language skills at the 5th grade reading level. 4. Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe. 5. Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires. 6. Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months). 7. Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating. 8. Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance. 9. Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included. 10. Participants cannot have a history of bariatric surgery 11. Participants cannot currently be enrolled in an organized weight control program.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

Location

Related Publications (4)

• Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.

  PMID: 22122291 BACKGROUND

• Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.

  PMID: 24459240 BACKGROUND

• Boutelle KN, Pasquale EK, Strong DR, Eichen DM, Peterson CB. Reduction in eating disorder symptoms among adults in different weight loss interventions. Eat Behav. 2023 Dec;51:101787. doi: 10.1016/j.eatbeh.2023.101787. Epub 2023 Jul 24.

  PMID: 37639734 DERIVED

• Boutelle KN, Eichen DM, Peterson CB, Strong DR, Kang-Sim DE, Rock CL, Marcus BH. Effect of a Novel Intervention Targeting Appetitive Traits on Body Mass Index Among Adults With Overweight or Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212354. doi: 10.1001/jamanetworkopen.2022.12354.

  PMID: 35583870 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Hyperphagia; Body Weight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Kerri Boutelle, Ph.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 6, 2015
• Study Start: September 1, 2015
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (1)