NCT06280339

Brief Summary

The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management. The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 16, 2024

Last Update Submit

February 26, 2024

Conditions

ObesityFood CravingsWeight Loss

Keywords

Food cravingsStrategiesWeight loss

Outcome Measures

Primary Outcomes (4)

  • Body weight

    Body weight in kilograms measured on a standard scale

    Change from baseline (0 month) to 3 month

  • Food Craving Strategies Compliance

    Bi-weekly questionnaires will be utilized to assess adherence to the strategies and the state of food cravings. The state of food cravings will be measured using a visual analog scale. Adherence to the strategies will be assessed using a Likert scale based on three areas: 1. Difficulty of implementing the strategies, ranging from '1=Very difficult' to '5=Not difficult'. 2. The frequency of using the strategies ranges from '1=Never' to '5=Every day'. 3. Effectiveness of the strategies in managing food cravings, ranging from '1=Not helpful' to '5=Very helpful'.

    Change from baseline 0 week to 12 week runs-bi-weekly

  • Food Cravings

    The Food Cravings Questionnaire-Trait (FCQ-T) evaluates craving traits through 39 statements. Respondents use a Likert scale ranging from 1, "Never" or "Not Applicable" (NA), to 6, "Always" or "Almost every day".

    Change from baseline 0 week to 6 week and week 12

  • Food Cravings

    The Food Craving Inventory (FCI) assesses the frequency of food cravings based on 28 food items. Participants rate the frequency of their cravings using a Likert scale ranging from 1, "Never", to 5, "Always" or "Almost every day".

    Change from baseline 0 week to 6 week and week 12

Secondary Outcomes (1)

  • Dietary intake

    Baseline. month 1, month 3

Study Arms (2)

Avoidance group

EXPERIMENTAL

Avoidance Strategy: This strategy focuses on teaching individuals how to modify their immediate environments to make it easier to control food cravings. Examples include redesigning your home to remove tempting foods or limiting access to craved foods. It also covers tips on making grocery lists and communicating health goals within your social circle. Additionally, it includes a toolkit for situations where controlling the immediate environment may be challenging, such as at parties or social gatherings Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings.

Behavioral: Test two food cravings strategies during dietary weight lossBehavioral: Dietary weight loss program +Food cravings strategies

Inclusion group

EXPERIMENTAL

Inclusion Strategy: This strategy teaches individuals how to modify their eating habits by paying attention to the portion size of craved foods and incorporating them into well-balanced meals, avoiding eating between meals. It also includes a toolkit for situations where individuals may struggle to include craved foods in their balanced meals. Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings.

Behavioral: Test two food cravings strategies during dietary weight lossBehavioral: Dietary weight loss program +Food cravings strategies

Interventions

Test two food cravings strategies during dietary weight lossBEHAVIORAL

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Avoidance groupInclusion group
Dietary weight loss program +Food cravings strategiesBEHAVIORAL

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Avoidance groupInclusion group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult between the ages of 18 and 75
  • BMI of at least 28 and above
  • Have access to the internet 3- Report experiencing at least a moderate amount of food cravings, and they consume the craved food at least a few times per week.

You may not qualify if:

  • Participation in a formal weight management program within the preceding three months.
  • Usage of medications impacting weight.
  • Being pregnant or breastfeeding.
  • Having a history of bariatric surgeries.
  • Diagnosed with DM type 1 or/and Use insulin injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bevier HAll UIUC

Urbana, Illinois, 61801, United States

RECRUITING

Bevier HAll UIUC

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (18)

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    PMID: 39380201BACKGROUND

  • American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Expert Panel, 2013. Executive summary: Guidelines (2013) for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society published by the Obesity Society and American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Based on a systematic review from the The Obesity Expert Panel, 2013. Obesity (Silver Spring). 2014 Jul;22 Suppl 2:S5-39. doi: 10.1002/oby.20821. No abstract available.

    PMID: 24961825BACKGROUND

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    PMID: 22098808BACKGROUND

  • Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.

    PMID: 17341711BACKGROUND

  • Finley CE, Barlow CE, Greenway FL, Rock CL, Rolls BJ, Blair SN. Retention rates and weight loss in a commercial weight loss program. Int J Obes (Lond). 2007 Feb;31(2):292-8. doi: 10.1038/sj.ijo.0803395. Epub 2006 Jun 6.

    PMID: 16755283BACKGROUND

  • Lee MH, Applegate CC, Shaffer AL, Emamaddin A, Erdman JW Jr, Nakamura MT. A feasibility study to test a novel approach to dietary weight loss with a focus on assisting informed decision making in food selection. PLoS One. 2022 May 26;17(5):e0267876. doi: 10.1371/journal.pone.0267876. eCollection 2022.

    PMID: 35617305BACKGROUND

  • Boswell RG, Kober H. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review. Obes Rev. 2016 Feb;17(2):159-77. doi: 10.1111/obr.12354. Epub 2015 Dec 8.

    PMID: 26644270BACKGROUND

  • Hill AJ. The psychology of food craving. Proc Nutr Soc. 2007 May;66(2):277-85. doi: 10.1017/S0029665107005502.

    PMID: 17466108BACKGROUND

  • Jakubowicz D, Froy O, Wainstein J, Boaz M. Meal timing and composition influence ghrelin levels, appetite scores and weight loss maintenance in overweight and obese adults. Steroids. 2012 Mar 10;77(4):323-31. doi: 10.1016/j.steroids.2011.12.006. Epub 2011 Dec 9.

    PMID: 22178258BACKGROUND

  • Hill AJ, Weaver CF, Blundell JE. Food craving, dietary restraint and mood. Appetite. 1991 Dec;17(3):187-97. doi: 10.1016/0195-6663(91)90021-j.

    PMID: 1799281BACKGROUND

  • Weingarten HP, Elston D. Food cravings in a college population. Appetite. 1991 Dec;17(3):167-75. doi: 10.1016/0195-6663(91)90019-o.

    PMID: 1799279BACKGROUND

  • White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.

    PMID: 11836456BACKGROUND

  • Gendall KA, Joyce PR, Sullivan PF. Impact of definition on prevalence of food cravings in a random sample of young women. Appetite. 1997 Feb;28(1):63-72. doi: 10.1006/appe.1996.0060.

    PMID: 9134095BACKGROUND

  • Chao AM, Jastreboff AM, White MA, Grilo CM, Sinha R. Stress, cortisol, and other appetite-related hormones: Prospective prediction of 6-month changes in food cravings and weight. Obesity (Silver Spring). 2017 Apr;25(4):713-720. doi: 10.1002/oby.21790.

    PMID: 28349668BACKGROUND

  • Gilhooly CH, Das SK, Golden JK, McCrory MA, Dallal GE, Saltzman E, Kramer FM, Roberts SB. Food cravings and energy regulation: the characteristics of craved foods and their relationship with eating behaviors and weight change during 6 months of dietary energy restriction. Int J Obes (Lond). 2007 Dec;31(12):1849-58. doi: 10.1038/sj.ijo.0803672. Epub 2007 Jun 26.

    PMID: 17593902BACKGROUND

  • Appelhans BM, French SA, Pagoto SL, Sherwood NE. Managing temptation in obesity treatment: A neurobehavioral model of intervention strategies. Appetite. 2016 Jan 1;96:268-279. doi: 10.1016/j.appet.2015.09.035. Epub 2015 Oct 22.

    PMID: 26431681BACKGROUND

  • Roe LS, Rolls BJ. Which strategies to manage problem foods were related to weight loss in a randomized clinical trial? Appetite. 2020 Aug 1;151:104687. doi: 10.1016/j.appet.2020.104687. Epub 2020 Mar 29.

    PMID: 32234531BACKGROUND

  • Forman EM, Hoffman KL, Juarascio AS, Butryn ML, Herbert JD. Comparison of acceptance-based and standard cognitive-based coping strategies for craving sweets in overweight and obese women. Eat Behav. 2013 Jan;14(1):64-8. doi: 10.1016/j.eatbeh.2012.10.016. Epub 2012 Nov 15.

    PMID: 23265404BACKGROUND

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Central Study Contacts

Manabu Nakamura, PhD

CONTACT

217-333-1267mtnakamu@illinois.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 28, 2024

Study Start

January 29, 2024

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

US(2)